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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

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Mar 11, 2016 Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only ... Integra's post QA release review of historical product release test results for Meshed IDRT produ... Class II Integra LifeSciences Corporation
Mar 9, 2016 Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Mo... Panorama Central Station including the work station View Station, View Station and the eGateway w... Class II Mindray DS USA, Inc. dba Mindray North America
Mar 7, 2016 Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Reports relating to unintended patient or operator burns or operator electric shock for some of I... Class II Integra LifeSciences Corp.
Mar 7, 2016 Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Reports relating to unintended patient or operator burns or operator electric shock for some of I... Class II Integra LifeSciences Corp.
Mar 3, 2016 Hand-Held Scanner USB IT3800 For sample identification and tracking when use... The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identifie... Class II Roche Molecular Systems, Inc.
Feb 23, 2016 Custom Tubing Packs Custom tubing pack for oxygenators Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016 HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016 QUADROX-i oxygenators Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016 Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 22, 2016 Video Duodenoscope Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a... Class II Pentax Medical Company
Jan 29, 2016 Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. ... It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from star... Class II Valeant Pharmacueticals International
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temp... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the tempor... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for th... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 13, 2016 The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization... Water retention issues. Units with filters that remain wet after the sterilization may compromis... Class II PMBS, LLC
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
Dec 23, 2015 Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instruct... Class II Stryker Howmedica Osteonics Corp.
Dec 23, 2015 Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleani... This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 18, 2015 Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manu... Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. Class II Stryker Spine
Dec 16, 2015 AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody de... There were two potential interference conditions identified with the way the tubing set attaches ... Class II Stryker Spine
Dec 16, 2015 Cardiosave Hybrid and rescue IABP Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet... Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 15, 2015 Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View S... An issue with the Panorama Central Station may cause the system to spontaneously restart. This ma... Class II Mindray DS USA, Inc. dba Mindray North America
Dec 10, 2015 Flow-i Anesthesia System Product Usage: The indication for the Flow-i Ane... Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit ... Class I Maquet Cardiovascular Us Sales, Llc
Dec 9, 2015 BD Intelliport Medication Management System Sensor The system is indicated... The sterility of the product cannot be assured. This may result in increased risk of infection. Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemo... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The... Stability data does not substantiate the labeled two-year shelf life of affected product. Class II Ethicon, Inc.
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Nov 23, 2015 Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshiel... Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion S... Class II Terumo Medical Corp

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.