Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 39,969 FDA device recalls.

DateProductReasonClassFirm
Dec 6, 2023 Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the fo... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883 Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm The microcatheter IFU contains an intended use that has not been evaluated by the FDA. Class II Stryker, Inc.
Dec 6, 2023 Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 m... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100,... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm The microcatheter IFU contains an intended use that has not been evaluated by the FDA. Class II Stryker, Inc.
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultras... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Ec... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Ec... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Instructions for Use have been updated to add the following warning: Use only M4 screws with the ... Class II Ambu Inc.
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echoca... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 4, 2023 Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... Class II Olympus Corporation of the Americas
Dec 4, 2023 Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DR... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch se... Class II Olympus Corporation of the Americas
Dec 4, 2023 Model No. CYF-5, Cystonephrofiberscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Model No. BF-P190, EVIS EXERA III Bronchovideoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE,... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Model No. CYF-5R, Cystonephrofiberscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC,... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRA... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Model No. BF-XP190, EVIS EXERA III Bronchovideoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, ... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 4, 2023 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150... The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... Class II Olympus Corporation of the Americas
Dec 4, 2023 TRACH KIT W/HYDROGEN & SALI Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PRO... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Model No. CYF-V2, VISERA Cysto-Nephro Videoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th... Class II Shirakawa Olympus Co., Ltd.
Dec 1, 2023 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... Class II Maquet Cardiovascular, LLC
Dec 1, 2023 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Pa... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.