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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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Aug 8, 2018 Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:008... The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging ... Class II Philips North America LLC
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Us... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Produc... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Produc... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 1, 2018 Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ... Potentially counterfeit products in/and counterfeit packaging were imported to the U.S. Class II Allied Vision Group Inc
Jul 19, 2018 Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model ... A small number of devices in this lot may have a melted cap and a hole formed through the packagi... Class II Beaver Visitec
Jul 10, 2018 HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... Class II Arrow International Inc
Jul 10, 2018 HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... Class II Arrow International Inc
Jun 29, 2018 Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manua... Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... Class II Quasar Bio-Tech, Inc.
Jun 29, 2018 Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual.... Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... Class II Quasar Bio-Tech, Inc.
Jun 29, 2018 Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Hand... Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... Class II Quasar Bio-Tech, Inc.
Jun 22, 2018 QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG

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.