Browse Device Recalls

2,093 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,093 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 2,093 FDA device recalls in NJ.

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DateProductReasonClassFirm
Jul 16, 2012 The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 DataCare POC  is an information management system that provides data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 5, 2012 Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spi... Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable... Class II Stryker Spine
Jul 3, 2012 Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seiza... Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load ... Class II Stryker Howmedica Osteonics Corp.
Jul 2, 2012 KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman,... Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA... Class II Mc-NEIL-PPC, Inc.
Jul 2, 2012 EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceu... Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in ass... Class II Ethicon, Inc.
Jun 15, 2012 STA Satellite Automated Multi-Parameter Analyzer This system is a fully au... Following a single customer complaint that incorrect INR values were occasionally printed for PT ... Class II Diagnostica Stago, Inc.
Jun 14, 2012 The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a ... Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guide... Class II Integra Life Sci.
Jun 12, 2012 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... It has come to firm's attention that, in some rare cases, the blood outlet connector on some mode... Class II Maquet Cardiovascular Us Sales, Llc
May 29, 2012 Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG K... Certain pediatric arterial cannulas may have limited flexibility due to an increased length of th... Class II Maquet Inc.
May 23, 2012 Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(... The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal co... Class II Integra Limited
May 7, 2012 V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Seri... Mindray has identified two software anomalies contained in the V Series Monitoring System. There... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
May 7, 2012 Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. Class II MTI Precision Products LLC.
Apr 30, 2012 Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate C... Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... Class II Stryker Howmedica Osteonics Corp.
Apr 30, 2012 ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 ... Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... Class II Stryker Howmedica Osteonics Corp.
Apr 25, 2012 The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDA... The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Ster... Class II Stryker Spine
Apr 23, 2012 LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spin... Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from... Class II Stryker Spine
Apr 23, 2012 Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqM... When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK softw... Class II Roche Molecular Systems, Inc.
Apr 20, 2012 Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bon... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft produ... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Optimum Expanse R Grafton is a human bone allograft product containing dem... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product ... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Optimum Expanse S Multiple sizes Grafton is a human bone allograft produc... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft p... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft produ... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograf... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft produc... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 13, 2012 Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Ver... As a result of a small number of customer complaints, MAQUET conducted an investigation and ident... Class II Maquet Medical Systems, Usa
Apr 4, 2012 Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. In... The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the de... Class II Integra LifeSciences Corp
Apr 3, 2012 Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distribut... The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the po... Class II Ethicon, Inc.
Apr 2, 2012 Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Ca... Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal thr... Class II Stryker Howmedica Osteonics Corp.
Mar 30, 2012 Model 324JL On-Board Suction System Intended use: On-board suction system f... A shipment mix-up took place. Class III Impact Instrumentation, Inc.
Mar 27, 2012 CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to i... In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly... Class II Maquet Cardiovascular, LLC
Mar 23, 2012 Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. b... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 ... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft ... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 22, 2012 Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. T... Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/... Class II Extremity Medical LLC
Mar 19, 2012 Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, Wes... Ten units of Model EMV+ Devices were shipped out in error before the verification and validation ... Class III Impact Instrumentation, Inc.
Mar 9, 2012 Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc B... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 9, 2012 Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation ... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 9, 2012 Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Roa... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 7, 2012 i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vit... Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit inc... Class II Abbott Point Of Care Inc.

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.