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Karl Storz Endoscopy FDA Recalls
53 recalls on file across devices, 0 of them Class I and 53 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: Class IIMay 21, 2026Flexible hysteroscopes indicated for use during diagnostic a |
| KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CEClass IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CEClass IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CEClass IIDec 19, 2024Due to failure of manual cleaning validation, biopsy and gra |
| KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Class IIDec 19, 2024Scope IFUs contain a reprocessing modalities that have not b |
| Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PCClass IIOct 21, 2024Due to improper labeling of products. An intended use on the |
| 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x Class IIOct 11, 2024Due to holes detected in the inner barrier system that may c |
| Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123Class IIJul 23, 2024Various medical device product IFUs contain reprocessing mod |
| LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000Class IIApr 1, 2024Laser surgical instruments have no specific evidence of a va |
| Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx OnlyClass IIFeb 27, 2024Inadequate reprocessing validation evidence |
| Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CEClass IIFeb 27, 2024Inadequate reprocessing validation evidence |
| Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx OnlyClass IIFeb 27, 2024Inadequate reprocessing validation evidence |
| Injection Needle, REF: 25207Class IIOct 24, 2023The efficacy of the manual cleaning process cannot be assure |
| Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182AClass IIOct 24, 2023The efficacy of the manual cleaning process cannot be assure |
| Injection Needle, LUER-lock,0.8mm, REF: 26175PDClass IIOct 24, 2023The efficacy of the manual cleaning process cannot be assure |
| Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Class IIOct 24, 2023The efficacy of the manual cleaning process cannot be assure |
| Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-dClass IIOct 24, 2023The efficacy of the manual cleaning process cannot be assure |
| Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx OnlyClass IIJul 7, 2023Flexible intubation endoscopes sterility assurance can not |
| Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm,Class IIApr 6, 2023Metal sterilization trays used to encase and protect medical |
| KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317AClass IIApr 5, 2023Plastic sterilization trays used to encase and protect medic |
| STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-Class IIMay 3, 2022The endoscope may experience a loss of image when activating |
| 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)Class IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOSClass IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); Class IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Class IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)Class IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Class IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XCClass IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)Class IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URClass IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW FClass IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro CysClass IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible VideoClass IIApr 1, 2022Failure to achieve the expected six-log reduction in microor |
| Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, IClass IIOct 15, 2021To ensure sterilization effectiveness, sterilization tray in |
| FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)Class IISep 10, 2021During a regular requalification review, affected flexible i |