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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

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

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DateProductReasonClassFirm
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 The product is Pathfinder SL, version 1.6.0.3057 software used with the Space... The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter ... Class II Spacelabs Healthcare, Llc
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL F... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefil... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10m... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefill... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Pr... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10m... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes in... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 10, 2012 Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascu... Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inf... Class II Perouse Medical
May 9, 2012 Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user ... The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. Class II SpineFrontier, Inc.
May 9, 2012 CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- G... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indica... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula ... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannul... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannu... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) The manufacturer informed the recalling firm of a potential laser marking error in size identific... Class II Aesculap, Inc.
May 9, 2012 Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is ind... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula i... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula a... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula an... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 Brand name: RayStation. Generic name: Treatment Planning System. Software ... The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, R... Class II RAYSEARCH LABORATORIES AB
May 9, 2012 Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Can... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula ... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHI... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannu... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Card... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 1... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occur... Class I Natus Medical Incorporated
May 9, 2012 SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MA... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems 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.