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Stryker Corporation FDA Recalls
96 recalls on file across devices, 0 of them Class I and 85 still open. Matched by name to SYK.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640Class IIJun 8, 2026There has been an increased amount in reported complaints co |
| STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540Class IIJun 8, 2026There has been an increased amount in reported complaints co |
| STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600Class IIJun 8, 2026There has been an increased amount in reported complaints co |
| STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620Class IIJun 8, 2026There has been an increased amount in reported complaints co |
| STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530Class IIJun 8, 2026There has been an increased amount in reported complaints co |
| Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management SystemClass IIMay 6, 2026It has been identified that the impacted docking station (SN |
| Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended toClass IIApr 9, 2026Due to nonconforming products being inadvertently distribute |
| MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 008500Class IIJan 21, 2026Due to a need to update the product labeling (Instructions f |
| NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath ShepClass IIOct 31, 2025Tape used to secure components within packaging contains lat |
| NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP Class IIOct 31, 2025Tape used to secure components within packaging contains lat |
| NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g IlluminatClass IIOct 31, 2025Tape used to secure components within packaging contains lat |
| Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3Class IIJul 2, 2025Tourniquet cuff flange may become detached from the bladder. |
| Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable TipClass IIJun 18, 2025Due to complaints their is the potential that irrigation sol |
| Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable TipClass IIJun 18, 2025Due to complaints their is the potential that irrigation sol |
| Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog NuClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)Class IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog NuClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog NumberClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog NumberClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITLClass IIFeb 25, 2025There is a potential for blister seals on the product to pre |
| Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197Class IIJan 29, 2025Increase in complaints concerning "pullwire" breakage that m |
| stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal BladesClass IIJan 8, 2025Precision Thin blade attachments have a potential to be out |
| stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal BladesClass IIJan 8, 2025Precision Thin blade attachments have a potential to be out |
| 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-00Class IIDec 3, 2024Bolts on the vacuum pump filter housing and the flange plate |
| Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurClass IIOct 4, 2024There is a potential for the product to activate without man |
| Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgicaClass IIOct 4, 2024There is a potential for the product to activate without man |
| Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgiClass IIOct 4, 2024There is a potential for the product to activate without man |
| Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical aClass IIOct 4, 2024There is a potential for the product to activate without man |
| Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appliClass IIOct 4, 2024There is a potential for the product to activate without man |
| Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosuClass IIOct 4, 2024There is a potential for the product to activate without man |
| 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bClass IISep 5, 2024May exhibit endotoxin levels greater than 2.15 EU/device, fe |
| Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reamingClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decortiClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming,Class IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,Class IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decortClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,Class IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decortiClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, dClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorClass IIJul 24, 2024Potential for the product to exhibit temperatures higher tha |
| The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially availableClass IIJun 3, 2024Expired Products distributed to customers |
| Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the Class IIJun 3, 2024Expired Products distributed to customers |
| This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula containClass IIJun 3, 2024Expired Products distributed to customers |
| Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, aClass IISep 13, 2023Expired product distributed |
| Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015Class IISep 11, 2023An error was identified on the expiration date of the produc |
| Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462Class IIAug 23, 2023Expired Product distributed |
| Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the usClass IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mClass IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows Class IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bClass IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bonClass IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a consClass IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement withClass IIAug 7, 2023Potential for the Break-Away Femoral Nozzle the applicator |
| SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, diClass IIJul 10, 2023Potential for current software to miscount when scanning in |
| stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgeryClass IIJun 28, 2023There is potential the device inside the package may not mat |
| The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neuroClass IIJun 28, 2023There is potential the device inside the package may not mat |
| stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgeryClass IIJun 28, 2023There is potential the device inside the package may not mat |
| SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200Class IIMar 2, 2023Fiber optic cables assembled with not enough epoxy on the pr |
| Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Class IIMar 1, 2023Not able to achieve desired pressure and not holding pressur |
| Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Class IIMar 1, 2023Not able to achieve desired pressure and not holding pressur |
| Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135Class IIMar 1, 2023Not able to achieve desired pressure and not holding pressur |
| Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Class IIMar 1, 2023Not able to achieve desired pressure and not holding pressur |
| Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Class IIMar 1, 2023Not able to achieve desired pressure and not holding pressur |
| Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Class IIMar 1, 2023Not able to achieve desired pressure and not holding pressur |
| Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjuncClass IIJan 25, 2023Triton Canister Software, Insert & Scanning Label may cause |
| Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.Class IIJan 25, 2023Triton Canister Software, Insert & Scanning Label may cause |
| Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjuncClass IIJan 25, 2023Triton Canister Software, Insert & Scanning Label may cause |
| 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopClass IIJan 14, 2022A software defect in the camera control unit (CCU) will caus |
| Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 Class IIFeb 26, 2021Their is a potential that Video Processor/Illuminators may e |