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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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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 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, P... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, P... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, P... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 7, 2019 BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 The luer could break and cause the device to leak or break off and get stuck in the fistula needl... Class II Becton Dickinson & Company
Mar 7, 2019 BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle... Class II Becton Dickinson & Company
Mar 6, 2019 IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program t... When a patient is selected in the patient data and another patient is selected prior to the displ... Class II Topcon Medical Systems, Inc.
Mar 5, 2019 Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... Class II Becton Dickinson & Company
Mar 5, 2019 Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07 The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... Class II Becton Dickinson & Company
Mar 1, 2019 BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use i... Leak from the septum assembly or the canister may burst under high pressure which could result in... Class II Becton Dickinson & Company
Mar 1, 2019 Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - ... Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... Class II Integra Limited
Mar 1, 2019 Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - ... Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... Class II Integra Limited
Mar 1, 2019 Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - P... Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... Class II Integra Limited
Feb 28, 2019 SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... Class I Becton Dickinson & Company
Feb 8, 2019 Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardio... Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled inc... Class I Maquet Cardiovascular Us Sales, Llc
Feb 1, 2019 NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... Potentially comingled, resulting in the product in the box potentially not matching the product o... Class II Zimmer Trabecular Metal Technology, Inc.
Feb 1, 2019 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... Class II Becton Dickinson & Company
Feb 1, 2019 NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... Potentially comingled, resulting in the product in the box potentially not matching the product o... Class II Zimmer Trabecular Metal Technology, Inc.
Feb 1, 2019 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... Class II Becton Dickinson & Company
Jan 24, 2019 AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mis... Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump... Class II Maquet Cardiovascular, LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Num... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuratio... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Par... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Dec 20, 2018 CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The C... Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customer... Class I TERRIFIC CARE LLC
Dec 19, 2018 Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340... Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Class II Reckitt Benckiser LLC
Dec 19, 2018 Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-987... Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Class II Reckitt Benckiser LLC
Dec 18, 2018 PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr... The sutures inside the packaging are not the same size or type as indicated on the label. Class II Ethicon, Inc.
Nov 29, 2018 Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration... A stability issue in the calibrators may cause calibration failures or atypical Quality Control r... Class II Ortho Clinical Diagnostics Inc
Nov 28, 2018 Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Int... The surgical technique is being updated to caution against misuse due to reports of cage fracture... Class II 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.