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: 900164 FEMORAL SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK 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: 900633 FAN FOLD SHEET 44 X 58 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: 9002164 FEMORAL 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: 9001402 PLASTIC SURGERY PACK 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: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002511 MINOR SURGICAL PACK 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: 9001298 PREMIUM ARTHROSCOPY 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: 900997 PERI-GYN SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001460 REYITO PLUS UROLOGY 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: 9002766 SHOULDER PACK Used by medical staff to perform sur... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002829 BASIC SURG 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: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001062 ARTHROSCOPY 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: 9001966 LIVER & PANCREAS SURGERY 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: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical st... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK 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: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900474 LAPAROSCOPY 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: 900052 MINOR PROCEDURE SURGICAL PACK 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: 9001300 NEURO-SPINE SURGICAL PACK 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: 9001765 MINOR LACERATION 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: 900521 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: 900281A LAPAROTOMY PACK Used by medical staff to perform s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002256 NEUROSURGERY 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 Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast De... Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the ... Class II Wfr/aquaplast Corp
Jan 7, 2016 Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001297 PREMIUM OBSTETRICAL 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: 9001061 PERI-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: 9002224 SURGICAL PACK Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900996 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: 9001294 PREMIUM CESAREAN 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: 900176 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: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900486 LAPAROSCOPY 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: 900032 UNIVERSAL DRAINAGE 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: 9001202 LAMINECTOMY PK Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900982 ARTHROSCOPY 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: 900740A ARTHROSCOPY 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: 9002899 CYSTO TUR 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: 9001771 MAYO STAND COVER STERILE 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: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001127 FOLEY CATHETER TRAY 16 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: 900012 OB SURGICAL PACK Used by medical staff to perform s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900774 INCISION AND DRAINAGE TRAY 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: 900540 WOUND MANAGEMENT TRAY III 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: 9001521 UROLOGY SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001771 MAYO STAND COVER STERILE 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: 900063 WOUND CLOSURE TRAY I Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, 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.