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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
Mar 7, 2013 MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0... It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown... Class II Maquet Cardiovascular, LLC
Mar 7, 2013 Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator s... When using the SERVO-i on battery power, in a very small number of cases, some battery modules di... Class I Maquet Cardiovascular Us Sales, Llc
Feb 23, 2013 Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. How... Stryker received reports from the field indicating that the handle detached from the cam of the B... Class II Stryker Howmedica Osteonics Corp.
Feb 14, 2013 BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 m... The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags whic... Class III Becton Dickinson & Company
Feb 12, 2013 Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in ... Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions alrea... Class II Integra LifeSciences Corp.
Feb 7, 2013 Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-50017... Increased risk of failure at the driver tip during screw insertion or removal. Class II Ebi, Llc
Feb 1, 2013 Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and can... The firm has received numerous complaints of the cannulated screw driver tip breaking during surg... Class II Integra LifeSciences Corp.
Jan 28, 2013 Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATES... Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a ... Class II Diagnostica Stago, Inc.
Jan 25, 2013 KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes... This product is not cleared for marketing in the US. Class II Mc-NEIL-PPC, Inc.
Jan 25, 2013 KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged ... This product is not cleared for marketing in the US. Class II Mc-NEIL-PPC, Inc.
Jan 25, 2013 KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz t... This product is not cleared for marketing in the US. Class II Mc-NEIL-PPC, Inc.
Jan 24, 2013 Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and ... The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" ... Class II Stryker Howmedica Osteonics Corp.
Jan 14, 2013 LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healt... Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condo... Class II Ansell Healthcare Products LLC
Jan 10, 2013 Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidew... The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the meas... Class II Extremity Medical LLC
Jan 7, 2013 Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecon... There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the... Class II Integra LifeSciences Corp.
Dec 28, 2012 CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: ... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 28, 2012 CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usag... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 27, 2012 Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is u... Surgeons have experienced unthreading of the screwdrivers outer shafts during use. Class II Stryker Spine
Dec 26, 2012 Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO)... ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. Class II Maquet Cardiovascular Us Sales, Llc
Dec 21, 2012 MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integ... Integra determined there is a possibility that the Base Units may break during use. Class II Integra LifeSciences Corp.
Dec 20, 2012 Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog N... Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. Class II Stryker Howmedica Osteonics Corp.
Dec 10, 2012 Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning... Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occu... Class II Integra LifeSciences Corp.
Nov 28, 2012 COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being u... Class II Roche Molecular Systems, Inc.
Nov 28, 2012 Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack.... Mindray has identified a software anomaly that may where, in the presence of an asystole, the Tel... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Nov 28, 2012 BS-200 Chemistry Analyzer Designed for clinical laboratory use. An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Nov 12, 2012 BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Ster... BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to ex... Class II Becton Dickinson & Company
Nov 8, 2012 ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides ar... With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become awa... Class I Stryker Howmedica Osteonics Corp.
Nov 2, 2012 Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 B... There is a potential issue with the screw tension of the extension device 1433.62A1 used with the... Class II Maquet Inc.
Oct 25, 2012 Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. Two complaints have been filed where Hoffman LRF Wires have broken during load bearing applicatio... Class II Stryker Howmedica Osteonics Corp.
Oct 23, 2012 Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF... Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting i... Class II Stryker Howmedica Osteonics Corp.
Oct 16, 2012 Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal s... Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printe... Class II Vital Signs Devices, a GE Healthcare Company
Oct 11, 2012 COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Auto... Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection... Class II Roche Molecular Systems, Inc.
Oct 10, 2012 Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Dia... Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibratio... Class II Alfa Wassermann, Inc.
Oct 2, 2012 Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Fran... BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the... Class II Becton Dickinson & Company
Sep 29, 2012 Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Broken screw insertor hardness was measured and found to be below the acceptable limits. Class II Ebi, Llc
Sep 28, 2012 Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pr... Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothro... Class II International Technidyne Corp.
Sep 24, 2012 Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manuf... Mindray has identified an issue with the V Series Monitor where the monitors touch screen may sto... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Sep 21, 2012 Diamigo i-Phone App The Diamigo app was intended for use as an educationa... Diamigo, a software application, was released through the i-Phone Global Store which inadvertentl... Class II sanofi-aventis US, Inc.
Sep 5, 2012 Mindray DPM5 Monitor, a vital signs monitor used on human patients in health... Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not b... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 22, 2012 Dual Tip Marker, Sterile Product Usage: A writing instrument intended... Dual Tip Marker has inconsistent ink flow on the black permanent ink side. Class III Viscot Medical LLC
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somer... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 13, 2012 Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue related to the carbon d... Class I Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 13, 2012 Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue related to the carbon d... Class I Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 9, 2012 Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head R... T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-... Class II Integra LifeSciences Corporation
Aug 9, 2012 Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotac... T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-... Class II Integra LifeSciences Corporation
Aug 9, 2012 Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine... Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... Class II Stryker Spine
Aug 9, 2012 Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pin... Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... Class II Stryker Spine

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.