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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
Jan 31, 2014 MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat E... The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardio... Class II Maquet Cardiovascular Us Sales, Llc
Jan 22, 2014 Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxi... Integra LifeSciences has identified through an investigation of complaints that there may be the ... Class II Integra LifeSciences Corp.
Jan 8, 2014 CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRAC... Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. Class II Veridex, LLC
Jan 8, 2014 Panaroma Central Station Product Usage: This device can view real time,... Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag... Class II Mindray DS USA, Inc. dba Mindray North America
Jan 6, 2014 cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cob... Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received ... Class II Roche Molecular Systems, Inc.
Jan 1, 2014 i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnos... Abbott Point of Care has determined that some individual patient results generated with the i-ST... Class II Abbott Point Of Care Inc.
Dec 19, 2013 Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulati... ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in n... Class II ITC-Nexus Dx
Dec 18, 2013 Specialty Straight Static Inserter Assembly Product Usage: This instru... Stryker has received complaints from customers relating to fracture along the weld that binds the... Class II Stryker Spine
Dec 6, 2013 Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) ... Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customi... Class II Stryker Howmedica Osteonics Corp.
Dec 5, 2013 Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Produc... The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. Class II Integra LifeSciences Corp.
Dec 5, 2013 Compressor Mini To provide a supply of dry, filtered compressed air for a ... Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. Class II Maquet Cardiovascular Us Sales, Llc
Nov 26, 2013 Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neu... Integra became aware through a complaint from a single non-US customer that if the optional SYS/D... Class II Integra LifeSciences Corp.
Nov 26, 2013 BD Interlink threaded lock cannula This is a locking blunt plastic cannula s... BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the pote... Class II Becton Dickinson & Company
Nov 20, 2013 Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single u... Stryker received reports from the field of the impaction plate dissociating/fracturing from the m... Class II Stryker Howmedica Osteonics Corp.
Nov 13, 2013 Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... Class II Integra LifeSciences Corp.
Nov 13, 2013 Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... Class II Integra LifeSciences Corp.
Nov 7, 2013 Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher S... Stryker became aware during laboratory testing that there is a potential that the seal integrity ... Class II Stryker Howmedica Osteonics Corp.
Oct 30, 2013 Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LL... Maquet has received an increase in the number of complaints for "self-activated/remains activated... Class II Maquet Cardiovascular, LLC
Oct 28, 2013 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 0854... Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential t... Class II Abbott Point Of Care Inc.
Oct 28, 2013 Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 25, 2013 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Ang... Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was iden... Class II Stryker Howmedica Osteonics Corp.
Oct 10, 2013 VariAx Compression Plating System Stryker received two reports indicating that during screw insertion under a high lateral angle a ... Class II Stryker Howmedica Osteonics Corp.
Oct 7, 2013 Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) P... Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the ... Class II Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2013 Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stry... Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was... Class II Stryker Howmedica Osteonics Corp.
Sep 30, 2013 Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM sur... Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a... Class II Stryker Howmedica Osteonics Corp.
Sep 30, 2013 Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surg... Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a... Class II Stryker Howmedica Osteonics Corp.
Sep 25, 2013 Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon L... Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab fai... Class II Ethicon, Inc.
Sep 24, 2013 Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short... Multiple complaints have reported that the hex tip of the torque wrench fracturing during final t... Class II Stryker Spine
Sep 24, 2013 Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Steri... Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off dur... Class II Ebi, Llc
Sep 20, 2013 Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use d... MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D).... Class II Maquet Cardiovascular, LLC
Sep 16, 2013 PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... Class I Pentax Medical Company
Sep 12, 2013 MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf... It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma... Class II Maquet Medical Systems USA
Sep 10, 2013 Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Ca... Integra LifeSciences has identified through an internal evaluation that in order to comply with U... Class II Integra Limited
Aug 29, 2013 Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Cla... An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not eas... Class II Integra LifeSciences Corp.
Aug 23, 2013 BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-914... BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer... Class II Becton Dickinson & Company
Aug 22, 2013 Surgicutt fully automated incision making device for bleeding time determinat... ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; L... Class II ITC-Nexus Dx
Aug 22, 2013 BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System... Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are ge... Class II Ebi, Llc
Aug 19, 2013 TEGRIS system Four labels of the Tegris System include: Emergency butt... MAQUET has identified a potential issue that might occur because of the lack of an emergency stop... Class II Maquet Cardiovascular Us Sales, Llc
Aug 15, 2013 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... The manufacturer has conducted a review of the results of product testing performed during the la... Class II Maquet Cardiovascular Us Sales, Llc
Aug 13, 2013 Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Sc... Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. Class II Ebi, Llc
Jul 31, 2013 Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic image... A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which include... Class II Fujinon Inc
Jul 25, 2013 KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System... During an internal investigation, a formulation error that occurred was identified during the man... Class II Roche Molecular Systems, Inc.
Jul 18, 2013 Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 un... GE Healthcare has become aware of a potential safety issue associated with the use of GE General ... Class II Vital Signs Devices, a GE Healthcare Company
Jul 17, 2013 Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hard... As a result of complaint investigations it was identified that there is a potential that the Leyl... Class II Integra Limited
Jul 10, 2013 BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length R... The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. Class II Becton Dickinson & Company
Jul 10, 2013 Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A... TempaDot products may have been mislabeled. Class II Medical Indicators, Inc.
Jul 8, 2013 Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) ... Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot... Class II Stryker Howmedica Osteonics Corp.
Jul 2, 2013 Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedul... Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. 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.