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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

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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
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DUR PCA MTK REV INS LFT Intended for knee replacement Product Number:... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 7... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... Class II Maquet Cardiovascular, LLC
Dec 1, 2023 PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Prod... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Nov 27, 2023 Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear M... Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall dow... Class II Mirion Technologies (Capintec), Inc.
Nov 20, 2023 KeySplint Hard Clear - Indicated for the fabrication of orthodontic and denta... Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instr... Class II Keystone Industries
Nov 16, 2023 PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syri... An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with... Class II Becton Dickinson & Company
Nov 14, 2023 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ... CARDIOHELP-i System was not properly tested to measure leakage current Class III Maquet Medical Systems USA
Nov 13, 2023 Venous probe connection cable (REF 701069333 and 701048804) used with the Car... Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe con... Class II Maquet Medical Systems USA
Nov 8, 2023 Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD ... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - A... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and P... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AX... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E -... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light S... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF ... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Ca... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numb... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Cata... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 6, 2023 CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxid... Certain factory settings for the device were incorrectly described in the IFU-related to the warn... Class II Maquet Medical Systems USA
Nov 1, 2023 LITe Decompression Snake Arm, REF 48080230 Product arm was manufactured with the incorrect clamp component. As a result, the affected produc... Class II Stryker Spine
Nov 1, 2023 Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... Class II Turncare, Inc
Oct 31, 2023 Acrobat-i Vacuum Positioner System, Model Number XP-5000Z The Positioner Arm may not tighten or lock during normal use. Class II Maquet Cardiovascular, LLC
Oct 31, 2023 ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M The organization completed a product improvement process to the conjugate found within the certai... Class II Zeus Scientific, Inc.
Oct 31, 2023 ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G The organization completed a product improvement process to the conjugate found within the certai... Class II Zeus Scientific, Inc.
Oct 31, 2023 The 4Kscore Test, an in vitro serum or plasma test that combines the results ... Mathematical modeling of the 4Kscore with and without DRE information was recently performed on o... Class II BioReference Health, LLC
Oct 19, 2023 Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoi... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences 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.