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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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Apr 19, 2024 Patient Information Center iX and Patient Information Center iX Expand, Softw... Event Catalog information does not save when copied and transferred from one unit to another. Class II Philips North America Llc
Apr 18, 2024 OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-2... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... Class II Exactech, Inc.
Apr 18, 2024 OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26M... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... Class II Exactech, Inc.
Apr 18, 2024 OES 4000 Hysteroscope, Model/Catalog Number: A4674A The required leakage test was not performed following of a re-work for a non-conformity. This cou... Class II Olympus Corporation of the Americas
Apr 18, 2024 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitr... When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is co... Class II Beckman Coulter, Inc.
Apr 18, 2024 Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R... Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system chec... Class II Boston Scientific Neuromodulation Corporation
Apr 18, 2024 Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545,... A small number of devices may have a higher probability of a crack within the internal electronic... Class II MED-EL Elektromedizinische Gereate, Gmbh
Apr 18, 2024 The Synchro Neuro Guidewires are a steerable guidewire family with a shapeabl... Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... Class II Stryker Neurovascular
Apr 18, 2024 The Synchro SELECT Guidewires are a steerable guidewire family with a shapeab... Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... Class II Stryker Neurovascular
Apr 18, 2024 DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic ... Class II Beckman Coulter, Inc.
Apr 18, 2024 OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... Class II Exactech, Inc.
Apr 18, 2024 OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... Class II Exactech, Inc.
Apr 18, 2024 Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the... Class I OptumHealth Care Solutions LLC
Apr 18, 2024 Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 Sma... Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing del... Class II BD SWITZERLAND SARL
Apr 18, 2024 The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip... Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... Class II Stryker Neurovascular
Apr 17, 2024 Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S ... Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... Class II YAMAHA MOTOR CORPORATION
Apr 17, 2024 Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YS... Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... Class II YAMAHA MOTOR CORPORATION
Apr 17, 2024 Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881,... These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. L... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... Potential contamination of the product with latex adhesive residual. Class II Cardinal Health 200, LLC
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular gra... The guide tip can become damaged and result in the tip detaching. Class II LeMaitre Vascular, Inc.
Apr 17, 2024 Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may com... Class II Integra LifeSciences Corp.
Apr 17, 2024 Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended ... X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a fa... Class II NRT X-RAY A/S
Apr 17, 2024 Blood Pump Rotor, Model Number: F40015481 Rev A An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 16, 2024 EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardi... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Rad... A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. Class II Reflexion Medical, Inc.
Apr 16, 2024 PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardi... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Product not distributed in the US. Implantable Cardioverter Defibrillators: ... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Stryker Blueprint Software, Catalog #BPUE001. The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented impla... Class II Tornier S.A.S.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.

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.