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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

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

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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
Jul 1, 2016 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentatio... The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Class II Mentor Texas, LP.
Jul 1, 2016 Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reus... Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. Class II Stryker Howmedica Osteonics Corp.
Jul 1, 2016 OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... Class II Nidek Inc
Jul 1, 2016 Integra External Fixation System Rocker Bottom Model # 12225400. For use i... The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose ... Class II Integra LifeSciences Corp.
Jul 1, 2016 The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressur... Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. Class III Circulatory Technology Inc
Jul 1, 2016 The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB... The seal between the balloon and the housing may leak. Class II Circulatory Technology Inc
Jul 1, 2016 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/R... The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becomi... Class II Spacelabs Healthcare Inc
Jul 1, 2016 120 V Neptune 3 Rover, Model Number: 0703-001-000 Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potent... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2016 Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 serie... There is an observed failure of the backrest bracket which can fatigue over the life time of the ... Class II Sunrise Medical (US) LLC
Jul 1, 2016 DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... Class I Carefusion 2200 Inc
Jun 30, 2016 Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint meta... Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging o... Class II Zimmer Gmbh
Jun 30, 2016 Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incuba... An internal review of an available product found that the Information For Use only contained Engl... Class III C.R. Bard, Inc.
Jun 30, 2016 PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intend... Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212... Class II MicroPort Orthopedics Inc.
Jun 30, 2016 Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled ster... Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrumen... Class II Zimmer Biomet Spine, Inc
Jun 30, 2016 Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled ... Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrumen... Class II Zimmer Biomet Spine, Inc
Jun 30, 2016 AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indic... Vision RT Ltd received three (3) reports from different sites that discovered the following issue... Class II Vision RT Ltd
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System... Vision RT Ltd received three (3) reports from different sites that discovered the following issue... Class II Vision RT Ltd
Jun 29, 2016 TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intende... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK St... Labeling problem Class III C.R. Bard, Inc.
Jun 29, 2016 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored... The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... Class II Carefusion 2200 Inc
Jun 29, 2016 TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for... TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... Class II TYRX Inc.
Jun 29, 2016 TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabi... TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... Class II TYRX Inc.
Jun 29, 2016 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module ... The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... Class II Carefusion 2200 Inc
Jun 29, 2016 TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabiliz... TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... Class II TYRX Inc.
Jun 29, 2016 TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended u... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Ch... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, r... ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jun 28, 2016 Spirit Select Bed, A-C Powered Hospital Bed Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered... Class II CHG Hospital Beds Inc
Jun 28, 2016 BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with softw... In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be un... Class II B-K Medical A/S
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 28, 2016 Spirit Plus Bed, A-C Powered Hospital Bed Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered... Class II CHG Hospital Beds Inc
Jun 28, 2016 Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm... It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Sta... Class II Synthes (USA) Products LLC
Jun 28, 2016 NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, St... Wire in tubing can become exposed, posing potential harm to the intubated patient. Class II Medtronic Xomed, Inc.
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 27, 2016 CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Su... After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade c... Class II Aspen Surgical Puerto Rico Corp.
Jun 27, 2016 TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill hole... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel Dx... Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and th... Class II Beckman Coulter Inc.
Jun 27, 2016 The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam... Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi... Class II Cardinal Health
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill ho... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed 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.