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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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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

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
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.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D1, 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 EVERA MRI S VR SureScan, Model Number DVMC3D4, 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 15, 2024 BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Apr 15, 2024 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... Class II Philips North America Llc
Apr 15, 2024 MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H39... There is a potential issue regarding the service handles for the internal lead (Pb) covers in tha... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Apr 15, 2024 Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal... Potential damage to the cartridge can result in poor staple formation and/or incomplete staple li... Class II Covidien, LP
Apr 15, 2024 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... Class II Philips North America Llc
Apr 15, 2024 BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 BD Pyxis MedStation ES, REF: 323, Medication Cabinet Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Apr 15, 2024 BD Pyxis" Anesthesia Station ES, REF: 327 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Apr 15, 2024 BD Pyxis(TM) Anesthesia Station 4000, REF: 338 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. The firm identified that the measured patient leakage current in some devices significantly excee... Class II Maquet Medical Systems USA
Apr 12, 2024 APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used w... Screw is 16mm long instead of 22mm long. Class II Medartis Inc.
Apr 11, 2024 Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanica... Class II FUJIFILM Healthcare Americas Corporation

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.