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Olympus Corporation of the Americas FDA Recalls

348 recalls on file across devices, 44 of them Class I and 328 still open. Matched by name to OLYMY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Class IIAug 19, 2026Potential for detachment of ceramic tip due to manufacturing
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Class IIAug 19, 2026Potential for detachment of ceramic tip due to manufacturing
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Class IIAug 19, 2026Potential for detachment of ceramic tip due to manufacturing
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.Class IIAug 19, 2026Potential for the inflation chart label affixed to the shaft
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Class IIAug 19, 2026Potential for detachment of ceramic tip due to manufacturing
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cuttingClass IIAug 18, 2026Potential labeling deficiency in which an outer shelf box is
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displayiClass IIJul 7, 2026Potential for the HDMI and DisplayPort (DP) connectors can b
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4Class IIJun 16, 2026Potential for unexpected instances where the front panel dis
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designeClass IIJun 5, 2026Olympus has developed and released newly designed version of
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.Class IIMay 5, 2026Some sterilization parameters included in the IFU may not co
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.Class IIMay 5, 2026Some sterilization parameters included in the IFU may not co
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.Class IIMay 5, 2026Some sterilization parameters included in the IFU may not co
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.Class IIMay 5, 2026Some sterilization parameters included in the IFU may not co
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OEClass IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.Class IIMar 25, 2026XXX
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.Class IIMar 25, 2026Potential for the Version 2 reprocessor connecting tube lock
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.Class IIMar 23, 2026Potential for detachment of a distal tip component of the de
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.Class IIMar 23, 2026Potential for detachment of a distal tip component of the de
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.Class IIMar 23, 2026Potential for detachment of a distal tip component of the de
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.Class IIMar 23, 2026Potential for detachment of a distal tip component of the de
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Class IIFeb 27, 2026Following a complaint investigation, Olympus identified a po
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Class IIFeb 27, 2026Following a complaint investigation, Olympus identified a po
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps MoClass IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HAClass IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/CaClass IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK ProdClass IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000Class IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 ProClass IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK PrClass IIFeb 25, 2026Olympus identified that the Cutting Forceps contain componen
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.Class IIFeb 12, 2026The MAJ-1443 and MAJ-1444 are no longer reprocessing compati
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.Class IIFeb 12, 2026The MAJ-1443 and MAJ-1444 are no longer reprocessing compati
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.Class IIFeb 12, 2026The MAJ-1443 and MAJ-1444 are no longer reprocessing compati
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.Class IIFeb 12, 2026The MAJ-1443 and MAJ-1444 are no longer reprocessing compati
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to beClass IIJan 29, 2026Potential for rubber fragment detachment during use.
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to Class IIJan 29, 2026Potential for rubber fragment detachment during use.
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automaClass IJan 16, 2026Issue with software algorithm which may lead to overpressure
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automaticClass IJan 16, 2026Issue with software algorithm which may lead to overpressure
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatClass IJan 16, 2026Issue with software algorithm which may lead to overpressure
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - ReClass IIJan 8, 2026Mis-wired component-the improperly wired component can resul
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; SoftwareClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instrClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A ProductClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product DescriptioClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; SoftwareClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A ProductClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instrClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instrClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A ProductClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software VClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instrClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A ProductClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A ProductClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A ProductClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instrClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Class IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These insClass IIJan 7, 2026Devices which did not undergo thermoforming could deform and
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes MClass IINov 14, 2025Ongoing investigations identified additional instances of th
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Class IINov 14, 2025Ongoing investigations identified additional instances of th
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Class IINov 14, 2025Ongoing investigations identified additional instances of th
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatioClass IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applicatioClass IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatioClass IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applicationClass IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.Class IINov 11, 2025Complaints of the ceramic tip of the resection sheath breaki
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with anClass IOct 30, 2025Potential that the ligation loop was unable to release or de
Olympus Thunderbeat, 5 mm, 35 cm, Inline GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type SClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat, 5 mm, 20 cm, Inline GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat, 5mm, 35 cm, Pistol GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type SClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat 5 mm, 10 cm, Inline GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat, 5 mm, 45 cm, Pistol GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type SClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Olympus Thunderbeat, 5 mm, 45 cm Inline GripClass IIOct 22, 2025Firm is initiating a removal due to continued reports of adv
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate NephroClass IIOct 17, 2025Device kits contained an incorrectly sized 4mm x 4cm urinary
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Class IIOct 14, 2025Continued reports of positive cultures and infections have i
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T ProdClass IIOct 8, 2025The device may either fail to start up, or the transducer ma
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/CatalClass IIOct 6, 2025Sterility compromised from small holes that may occur during
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use ElectrosurgiClass IIOct 6, 2025Sterility compromised from small holes that may occur during
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2Class ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150Class ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180Class ISep 11, 2025Additional IFU updates to provide further clarification on s
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Class ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100Class ISep 11, 2025Additional IFU updates to provide further clarification on s
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60Class ISep 11, 2025Additional IFU updates to provide further clarification on s
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-ACClass ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170Class ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180Class ISep 11, 2025Additional IFU updates to provide further clarification on s
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190Class ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150Class ISep 11, 2025Additional IFU updates to provide further clarification on s
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170Class ISep 11, 2025Additional IFU updates to provide further clarification on s
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60Class ISep 11, 2025Additional IFU updates to provide further clarification on s
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device Class IAug 6, 2025Potential for undetected, deformed a-traumatic tips.
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEClass IIJul 25, 2025Potential for the ESG-410 Electrosurgical Generator to displ
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. Class IIJul 25, 2025Potential for the ESG-410 Electrosurgical Generator to displ
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seClass IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible Class IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are Class IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the bClass IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite Class IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible wClass IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible wClass IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessorClass IIJun 18, 2025Discrepancies between sterilization instructions in the Japa
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog NumClass IIMay 6, 2025Potential for thermal incident including an unexpected occur
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBClass IIMay 6, 2025Potential for thermal incident including an unexpected occur
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number:Class IIMay 6, 2025Potential for thermal incident including an unexpected occur
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/CataloClass IIMay 6, 2025Potential for thermal incident including an unexpected occur
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190VClass IIMay 5, 2025Recent post-market surveillance data suggests a possible ass
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog NumbersClass IIApr 4, 2025Preset treatment parameters are not consistently being used
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide SClass IJan 15, 2025Potential for the radiopaque tip of the guide sheath compone
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designClass IDec 18, 2024Potential for inadvertent retention of biomaterial when the
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V uClass IIDec 16, 2024Potential for distal tip tearing of the Mechanical Lithotrip
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated GriClass IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-Class IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-Class IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-aClass IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-Class IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-Class IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-aClass IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-Class IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, FrontClass IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-Class IINov 25, 2024The probe tips of the hand instruments are being damaged or
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-aClass IINov 25, 2024The probe tips of the hand instruments are being damaged or
Duravent Silicone Ventilation Tube. Model Number: 240075.Class IINov 19, 2024Potential that Duravent Silicone Ventilation Tubes may conta
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190Class IIOct 31, 2024High-level disinfection ("HLD") with Acecide-C disinfectant
Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 isClass IISep 24, 2024Does not meet the requirements for electromagnetic compatibi
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog NumbeClass IISep 18, 2024To better define the drying procedures described in the IFU
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;Class IISep 13, 2024Product being removed due to incompatibility when used in co
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A ProduClass IISep 13, 2024Olympus is removing the statement of compatibility with a Gr
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilatClass IISep 13, 2024Mislabeled Glo Cath Label (attached to the device) states: 1
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038Class IISep 11, 2024Exposure of the UroPass product to Ultraviolet ( UV ) Radiat
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327UClass IISep 4, 2024There was an increase in complaints indicating an occurrence
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)Class IIAug 23, 2024During product testing, Olympus identified an intermittent l
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100Class IIAug 21, 2024It was discovered during device performance testing that the
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vClass IIAug 13, 2024The term Bladder Stone was incorrectly translated in both Sp
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, andClass IIAug 13, 2024The term Bladder Stone was incorrectly translated in both Sp
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ouClass IIJul 1, 2024Fractures and breakages in packaging trays and Tyvek covers,
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ouClass IIJul 1, 2024Fractures and breakages in packaging trays and Tyvek covers,
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ouClass IIJul 1, 2024Fractures and breakages in packaging trays and Tyvek covers,
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation Class IIJun 21, 2024Electrosurgical Generators ESG-410 does not power on upon us
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWLClass IIMay 31, 2024Difficulties in pairing the wireless footswitch with the Sol
Soltive Pro SuperPulsed Laser System, Model TFL-SLSClass IIMay 31, 2024Difficulties in pairing the wireless footswitch with the Sol
Soltive Premium SuperPulsed Laser System, Model TFL-PLSClass IIMay 31, 2024Difficulties in pairing the wireless footswitch with the Sol
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a toClass IIApr 24, 2024A subset of the ES4K systems do not have complete records fo
OES 4000 Hysteroscope, Model/Catalog Number: A4674AClass IIApr 18, 2024The required leakage test was not performed following of a r
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid enClass IIApr 3, 2024Potential for distal end of the sheath to break off during a
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surClass IIMar 7, 2024Upon initial activation of the seal function, the POWERSEAL
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surClass IIMar 7, 2024Upon initial activation of the seal function, the POWERSEAL
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surClass IIMar 7, 2024Upon initial activation of the seal function, the POWERSEAL
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue Class IIMar 1, 2024Due to increase in complaints for the KD-640L and KD-645L T
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue Class IIMar 1, 2024Due to increase in complaints for the KD-640L and KD-645L T
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 ModeClass IIFeb 17, 2024A deterioration of the cutting knife, including overheating
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/CataClass IIFeb 17, 2024A deterioration of the cutting knife, including overheating
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )Class IIJan 29, 2024A non-compliant power cord may have been supplied in regions
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )Class IIJan 29, 2024A non-compliant power cord may have been supplied in regions
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prClass IIJan 16, 2024Water filter may have been assembled incorrectly, resulting
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. ModClass IIJan 16, 2024Japanese IFU version had slightly different language and ill
Colonoscope, Model Number CF-H180AL.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number PCF-H190TL.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number PCF-H180AL.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number PCF-H190L.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number PCF-HQ190L.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number PCF-H190DL.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number CF-HQ190I.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number CF-HQ190L.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number CF-Q180AL.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Colonoscope, Model Number PCF-Q180AL.Class IIJan 11, 2024Specific repaired colonovideoscopes were assembled without a
Hemostasis Probe, Model: CD-B622LAClass IIJan 5, 2024The BICOAG Hemostasis Probe with a coaxial plug was mispacka
ESG PK CUTTING FORCEPS, 5MM, 33CMClass IIDec 15, 2023The jaw may fracture prior to the procedure during the inspe
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis mediaClass IIDec 11, 2023The expiration date is missing from the primary (inner) pack
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to OlymClass IIDec 8, 2023Single Use Distal Cover MAJ-2315 may unexpectedly detach fro
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFCClass IIDec 4, 2023The strippers and cleavers are provided non-sterile and labe
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BSClass IIDec 4, 2023Affected products may potentially have a breached sterile po
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AClass IIDec 4, 2023The strippers and cleavers are provided non-sterile and labe
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBXClass IIDec 1, 2023Olympus identified inconsistencies in the Instructions for U
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, ligClass IINov 20, 2023Instructions for Use-User Deviations related to the reproces
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, lClass IINov 20, 2023Instructions for Use-User Deviations related to the reproces
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolesClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adultClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract inClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults andClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adultClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adulClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in aClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults aClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults aClass IINov 10, 2023Product balloon issues: inflating, deflating and/or retrievi
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light souClass IINov 6, 2023Reports of a pink or green coloration of the image. If the i
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-ACClass IOct 12, 2023There is a risk of endobronchial combustion if high-frequenc
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190Class IOct 12, 2023There is a risk of endobronchial combustion if high-frequenc
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180Class IOct 12, 2023There is a risk of endobronchial combustion if high-frequenc
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190Class IOct 12, 2023There is a risk of endobronchial combustion if high-frequenc
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMClass IOct 12, 2023There is a risk of endobronchial combustion if high-frequenc
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 ModelClass IOct 12, 2023There is a risk of endobronchial combustion if high-frequenc
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting LooClass IIOct 2, 2023Incorrect pouch labels, the contents within the mislabeled p
EVIS EXERA III Gastrointestinal VideoscopeClass IIOct 2, 2023Sterilization failures when devices are sterilized per the R
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GPClass IISep 28, 2023Fiberscopes do not have adequate data to support that the su
Insufflation unit, UHI-4.Class IISep 25, 2023Olympus has become aware of an increased trend of both repai
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.Class ISep 22, 2023There have been reports of patients suffering arrhythmias, r
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, lightClass IISep 14, 2023Certain serial numbers of the CV-190 do not start up properl
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including singlClass IISep 12, 2023Thunderbeats blue seal button may remain in the engaged posi
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including singClass IISep 12, 2023Thunderbeats blue seal button may remain in the engaged posi
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN AcClass IIAug 10, 2023Non-conformances in Veran devices (ig4 Image Guided System,
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19Class IIAug 10, 2023Non-conformances in Veran devices (ig4 Image Guided System,
Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440Class IIAug 10, 2023Non-conformances in Veran devices (ig4 Image Guided System,
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 AlwClass IIAug 10, 2023Non-conformances in Veran devices (ig4 Image Guided System,
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiNClass IIAug 10, 2023Non-conformances in Veran devices (ig4 Image Guided System,
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-56Class IIAug 10, 2023Non-conformances in Veran devices (ig4 Image Guided System,
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-3C160.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-XT190.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-MP190F.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VClass IIJul 27, 2023Recent reports of patient infection.
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.Class IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Olympus Bronchovideoscope, Model BF-Q180-ACClass IIJul 27, 2023Complaint of endoscope model becoming lodged in the endotrac
Visera Hysterovideoscope Olympus HYF Type VClass IIJul 20, 2023IFU labeling is being updated to revise EtO gas mixture and
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOClass IIJul 12, 2023The air/water valve MAJ-1444 used with OER-Pro and OER-Elit
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2Class IJun 8, 2023There have been complaints of endobronchial combustion durin
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160Class IJun 8, 2023There have been complaints of endobronchial combustion durin
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150Class IJun 8, 2023There have been complaints of endobronchial combustion durin
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatmeClass IIJun 8, 2023Additional Caution statements in IFU: (1) Due to complaints
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170Class IJun 8, 2023There have been complaints of endobronchial combustion durin
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190Class IJun 8, 2023There have been complaints of endobronchial combustion durin
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60Class IJun 8, 2023There have been complaints of endobronchial combustion durin
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180Class IJun 8, 2023There have been complaints of endobronchial combustion durin
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display mClass IIMay 26, 2023Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor l
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexiblClass IIMay 26, 2023Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor l
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to Class IIMay 26, 2023Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor l
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibClass IIMay 26, 2023Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor l
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibleClass IIMay 26, 2023Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor l
UroPass Ureteral Access Sheaths, 5 pieces/boxClass IIMay 19, 2023Dilator tips may break in the package and in patients during
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical intClass IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical Class IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in cliClass IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for useClass IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical intClass IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use Class IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in cClass IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical intervClass IIMay 15, 2023Electromagnetic (EM) sensor tracking malfunction impacts the
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Class IIMay 4, 2023Complaints on clip deployment occurring during clinical proc
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog NuClass IIMay 4, 2023Complaints on clip deployment occurring during clinical proc
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Class IIMay 4, 2023Complaints on clip deployment occurring during clinical proc
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog NuClass IIMay 4, 2023Complaints on clip deployment occurring during clinical proc
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: CClass IIApr 18, 2023The Single Use Distal Cover MAJ-2315 may cause mucosal injur
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle asClass IIIMar 31, 2023Product non-conformance pertaining to the angle of the needl
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural leClass IIIMar 31, 2023Product non-conformance pertaining to the angle of the needl
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Class IIFeb 23, 2023There have been complaints that the clip did not come out of
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anuClass IIDec 21, 2022A single CF-Q180AL colonovideoscope was utilized in a veteri
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)Class IIDec 13, 2022A grainy image is observed when using a SPiN Vision Single-U
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657SClass IINov 4, 2022An incompatible HF cable may be packaged with the HF Resecti
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.Class IISep 16, 2022Update to the Instruction for Use (IFU): Olympus is adding a
Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgiClass IIAug 12, 2022An out of specification component preventing the blue retent
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgiClass IIAug 12, 2022An out of specification component preventing the blue retent
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgiClass IIAug 12, 2022An out of specification component preventing the blue retent
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-SClass IIJul 7, 2022Mis-wired component-the improperly wired component can resul
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Class IIMay 26, 2022Device model and size for affected lots of Laser Fibers may
Colonovideoscope Model CF-H180ALClass IIApr 22, 2022A (Camera unit) CCD intended for a different model of colono
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, sClass IIApr 22, 2022Part (A-rubber) intended for a different model of gastrointe
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6RClass IIApr 20, 2022Incorrect adhesive used to secure the diopter ring and namep
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6Class IIApr 20, 2022Incorrect adhesive used to secure the diopter ring and namep
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5Class IIApr 20, 2022Incorrect adhesive used to secure the diopter ring and namep
Olympus DISPOSABLE GRASPING FORCEPS, FG-51DClass IIMar 31, 2022Forceps do not comply with Olympus standards for the amount
Olympus Uretero-reno videoscope, Model No. URF-V2Class IIMar 25, 2022The bending section of the URF-V2 may crack, resulting in an
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.Class IIMar 18, 2022GF-UC140P-AL5 is no longer a compatible endoscope for reproc
BF-MP160F: EVIS EXERA BronchofibervideoscopeClass IIMar 8, 2022Bronchofiberscope Updated instructions on the use of certain
BF-MP60: OES BronchofiberscopeClass IIMar 8, 2022Bronchofiberscope Updated instructions on the use of certain
BF-1TQ180: EVIS EXERA II BronchovideoscopeClass IIMar 8, 2022Bronchofiberscope Updated instructions on the use of certain
BF-3C160: EVIS EXERA BronchovideoscopeClass IIMar 8, 2022Bronchofiberscope Updated instructions on the use of certain
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortnClass IIDec 23, 2021Mislabeled Patient Charge Label indicating model number SVS-
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endosClass IIDec 13, 2021The detergent and alcohol tank tubing may have been incorrec
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180VClass IINov 2, 2021Use of a TJF-Q180V with adhesive deterioration or other dama
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple Class IISep 21, 2021Due to manufacturing error, the Pneumoliner Bag Distal Tab t
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160Class IIAug 17, 2021A gluing step was not performed during the manufacturing of
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-XP60 OES Bronchofiberscope, Model No. BF-XP60Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-ACClass IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160FClass IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-N20 OES Bronchofiberscope, Model No. BF-N20Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-P60 OES Bronchofiberscope, Model No. BF-P60Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160Class IIAug 16, 2021The firm is issuing validated, new reprocessing instructions
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, PClass IIAug 3, 2021Packaging seal defect may allow a breach of the package ster
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, exClass IIJun 30, 2021Thermal injury following dusting and fragmenting treatment o
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissueClass IIJun 9, 2021Expired adhesive used as an electrical insulation barrier an
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, doClass IIJan 28, 2021Olympus Medical Systems Corporation (OMSC) has received comp

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