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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.