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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

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
Sep 29, 2014 Integra Selector Kit Sterile single use device A bi-lumen, sterile single us... Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not pla... Class II Integra LifeSciences Corp.
Aug 21, 2014 TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In... The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen ... Class II Maquet Medical Systems USA
Aug 18, 2014 Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Irel... Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monito... Class II Integra LifeSciences Corp.
Aug 15, 2014 Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp.,... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 13, 2014 Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump Sys... An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the ... Class II Maquet Cardiovascular, LLC
Aug 11, 2014 LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group During label reconciliation a duplicate serial number label was detected to be printed for the LI... Class III Datascope Corporation
Aug 6, 2014 Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, S... Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes an... Class II Parker Laboratories, Inc.
Jul 31, 2014 Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 ... Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor be... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 24, 2014 Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-... Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a differ... Class II Stryker Howmedica Osteonics Corp.
Jul 22, 2014 BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL... BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306... Class II Becton Dickinson & Company
Jul 18, 2014 Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kit... Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (sub... Class III Diagnostica Stago, Inc.
Jul 17, 2014 Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis ... Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to i... Class II Genesis BPS, LLC.
Jul 17, 2014 Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC... Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to i... Class II Genesis BPS, LLC.
Jul 17, 2014 PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed c... Class II Pentax Medical Company
Jul 17, 2014 Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only... Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to i... Class II Genesis BPS, LLC.
Jul 9, 2014 Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat.... Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of rev... Class II Integra LifeSciences Corp.
Jul 7, 2014 Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is ... Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to comp... Class II Stryker Spine
Jul 7, 2014 Stryker Aria Implant Inserter, REF 48758500, This instrument is part of ... Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to comp... Class II Stryker Spine
Jul 3, 2014 BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 m... BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, r... Class II Becton Dickinson & Company
Jun 27, 2014 Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray ... Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility t... Class II Integra LifeSciences Corp.
Jun 20, 2014 Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro ... Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non... Class II ITC-Nexus Dx
Jun 12, 2014 EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope... Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory... Class II Pentax Medical Company
Jun 11, 2014 Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED... LED battery chargers may prematurely fail and will not charge the LED battery as intended Class II Integra LifeSciences Corp.
Jun 9, 2014 MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60... Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees of... Class II Integra LifeSciences Corp.
Jun 5, 2014 Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Tripl... There is a potential for a leak. A molding defect in the connector that joins the three leads t... Class II Excelsior Medical Corp
May 19, 2014 Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 ... This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that de... Class II Integra LifeSciences Corp.
May 19, 2014 V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. ... ECG interpretation feature issues. False measurements reported when the algorithm cannot determi... Class II Mindray DS USA, Inc. dba Mindray North America
May 15, 2014 Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrumen... The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. Class II Ebi, Llc
May 1, 2014 Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE P... Tritanium Patella Inserter Instrument fracture during implantation. . Class II Stryker Howmedica Osteonics Corp.
Apr 29, 2014 Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 ... Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition,... Class I Convatec Inc.
Apr 25, 2014 VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory s... The keyboard and monitor may not be properly secured to the monitor arm. Class III Siemens Medical Solutions Diagnostics
Apr 16, 2014 Maquet PowerLED 700. Product Usage; To provide illumination to the surgi... Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or sev... Class II Maquet Medical Systems USA
Apr 16, 2014 Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use wi... Integra LifeSciences has identified through a small number of complaints that some lot numbers of... Class II Integra LifeSciences Corp.
Mar 28, 2014 Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number... New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfi... Class II Integra LifeSciences Corporation
Mar 21, 2014 Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.... Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly... Class I Maquet Datascope Corp - Cardiac Assist Division
Mar 10, 2014 Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ ... Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert i... Class II Integra LifeSciences Corp.
Mar 5, 2014 DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor us... The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. Class II Mindray DS USA, Inc. dba Mindray North America
Mar 5, 2014 Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product ... Extremely low absorbance readings. Class II Alfa Wassermann, Inc.
Mar 5, 2014 Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product ... Extremely low absorbance readings. Class II Alfa Wassermann, Inc.
Feb 19, 2014 Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon I... The possibility exists that an incomplete seal on the packaging compromised the sterility of the ... Class II Ethicon, Inc.
Feb 7, 2014 Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Pr... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD1191... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Us... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: L... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Late... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Fol... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 3, 2014 IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are c... There is a potential for incorrect results to be reported from processing of a sample tube. Class II Siemens Medical Solutions Diagnostics
Feb 3, 2014 Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalo... Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angl... Class II Stryker Howmedica Osteonics 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.