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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
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 1, 2020 Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Shipments were transported outside of the required refrigerated temperature conditions. Potential... Class II Howmedica Osteonics Corp.
Mar 26, 2020 CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use On... The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. Class II Becton Dickinson & Company
Mar 23, 2020 B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-... Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by... Class II Janus Trade Group
Mar 17, 2020 PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Cat... Iincorrectly packaged without the required lidocaine as labeled Class II Becton Dickinson & Company
Mar 4, 2020 STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno... A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago inst... Class II Diagnostica Stago, Inc.
Mar 3, 2020 Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 -... It is possible that the collimators have screw hole locations that were insufficiently tapped. T... Class II Capintec Inc
Feb 26, 2020 BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025 The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278 The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276 The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435 The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 26, 2020 BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277 The kits contain surgical gowns which were subject to a recall by the supplier. Class II Becton Dickinson & Company
Feb 20, 2020 Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with... Class II Maquet Cardiovascular Us Sales, Llc
Feb 10, 2020 Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and... Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situ... Class II Maquet Cardiovascular Us Sales, Llc
Feb 7, 2020 NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product U... Nonconforming product which was dispositioned for rejection was mistakenly released for commercia... Class III Integra LifeSciences Corp.
Jan 16, 2020 Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Produ... Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th... Class III Maquet Cardiovascular Us Sales, Llc
Jan 16, 2020 Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Produ... Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th... Class III Maquet Cardiovascular Us Sales, Llc
Jan 15, 2020 i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 -... The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status... Class II Abbott Point Of Care Inc.
Jan 15, 2020 i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Pr... The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status... Class II Abbott Point Of Care Inc.
Jan 14, 2020 i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Pro... Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient ... Class II Abbott Point Of Care Inc.
Jan 13, 2020 DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - ... The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer. Class II Mindray DS USA, Inc. dba Mindray North America
Jan 3, 2020 Pentax Video Colonoscope Model: EC34-i10L Distributed in the USA without an approved 510K Class II Pentax of America Inc
Jan 3, 2020 Pentax Video Colonoscope Model: EC38-i10L Distributed in the USA without an approved 510K Class II Pentax of America Inc
Jan 3, 2020 Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The de... Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced t... Class II Ethicon, Inc.
Dec 16, 2019 VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/35... Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Product... Class II Ortho Clinical Diagnostics Inc
Dec 9, 2019 BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Cont... The gas spring on the front and rear protective cover may fail. There is a low risk of injury to... Class II Mindray DS USA, Inc. dba Mindray North America
Dec 9, 2019 ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ... The gas spring on the front and rear protective cover may fail. There is a low risk of injury to... Class II Mindray DS USA, Inc. dba Mindray North America
Dec 3, 2019 Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. ... A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console. Class II Maquet Cardiovascular Us Sales, Llc
Nov 20, 2019 Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is ... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 20, 2019 Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It i... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation

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.