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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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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.

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DateProductReasonClassFirm
Jan 11, 2016 Product 28 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 5 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 18 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 52 consists of product code: HWC and same usage: Item no: 52500453... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantit... N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... Class II Horiba Instruments Inc
Jan 11, 2016 Product 29 consists of all product under product code: LPHand same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 31 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 12 consists of all product under product code JDI , and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 48 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 25 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 8, 2016 SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an optio... Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. Thi... Class II DePuy Orthopaedics, Inc.
Jan 8, 2016 API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional tes... Discrepant identification results related to API identification strips. These discrepant identif... Class II BioMerieux SA
Jan 8, 2016 DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radia... In DS/US proton planning, there is a correction factor used internally to the dose engine that is... Class II Philips Medical Systems
Jan 8, 2016 Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: T... Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenos... Class II Olympus Corporation of the Americas
Jan 8, 2016 Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the res... Class II Natus Medical Incorporated
Jan 8, 2016 Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localizati... Product potentially exposed to body fluids during processing. Potential adverse events that may ... Class II Cook Inc.
Jan 8, 2016 Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intend... There is a possibility that the device may deliver a torque value less than the required setting ... Class II Orthofix, Inc
Jan 7, 2016 Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9%... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002940 OBSTETRICAL 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: 900010 SUTURE REMOVAL KIT 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: 9001933 OPHTALMIC 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: 900169 UNIVERSAL 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: 9001296 PREMIUM LAPAROTOMY 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: 9001738 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: 9002193 SHOULDER ARTHROSCOPY 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: 9002469 BASIC SURGICAL PACK IV 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: 9002510 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: 900629 STERILE OR CLOTH TOWEL BLUE 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: 900403 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: 9001198 WOUND MANAGE II 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: 900548A PERY-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: 900450 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: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by med... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF 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: 900278 URETHRAL CATHETER TRAY 14FR 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: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900741A ORTHO-IMPLANT 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: 900547 BASIC SURGICAL PACK Used by medical staff to perfo... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001154 WOUND MANAGEMENT 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: 900419 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 Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, ... MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension De... Class II Maquet Cardiovascular Us Sales, Llc
Jan 7, 2016 Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perfo... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical ... 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.