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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 7, 2023 Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco... Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distrib... Class II TERRAGENE S.A.
Dec 7, 2023 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... Class II Medtronic Inc.
Dec 7, 2023 MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Numb... The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static ... Class II Cook Medical Llc
Dec 7, 2023 Terragene Bionova PCD (PCD222-C) Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distrib... Class II TERRAGENE S.A.
Dec 7, 2023 Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray Syste... If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily ope... Class II Philips North America
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 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 PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG04... 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 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 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 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 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 Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Impella Connect, software portal for online device management that allows cli... The following features have been disabled from the web-based portal because the FDA has not evalu... Class II Abiomed, Inc.
Dec 6, 2023 Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, ... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) P... 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 RECOTHROM, Product Codes: a) ADS202105, 5m... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Accure Laser System, Model: PFMS00004 Laser system's spot tracking system may become misaligned resulting in the possible risk of deliv... Class II Accure Acne, Inc
Dec 6, 2023 Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC12... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 9340... 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 (GLOBAL), Product Codes: a) VG0108N: ... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
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 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 (General 3 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 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; G2 (GENERAL 2) -An Ultras... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
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 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 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 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 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 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 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 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. 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 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 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 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 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 PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Prod... 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-3000-W . Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... Class II Maquet Cardiovascular, LLC
Dec 1, 2023 PS LIPPED TIBIAL INSERT ASSY 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 TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -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.

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.