Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Jan 7, 2016 Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff t... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by me... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... Heartware Ventricular Assist System Battery Cell experiencing premature depletion. Class I Heartware, Inc.
Jan 7, 2016 Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AA... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical sta... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADUL... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff t... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Pr... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Pro... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Pro... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Single Lumen Central Venous Catheter Sets and Trays The subject sets and t... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject set... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Pro... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposabl... Firm was notified of a potential product defect related to kinking (flattening) of anesthesia ext... Class II Global Healthcare Inc
Jan 6, 2016 IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw... DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Can... Class II Synthes (USA) Products LLC
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 P... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Produ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Produc... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Pr... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Inst... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Pro... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.

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.