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Browse Device Recalls

395 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 395 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 395 FDA device recalls.

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DateProductReasonClassFirm
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.
Nov 25, 2013 HT Connect Peripheral Guide Wire Part Number Description 1012587 ... Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small nu... Class II Abbott Vascular, Inc.
Nov 23, 2013 The Abbott m2000sp is an automated system for performing sample preparation f... The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling a... Class II Abbott Molecular
Nov 18, 2013 FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Nov 18, 2013 FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Oct 31, 2013 Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly... Class I Hospira Inc.
Oct 31, 2013 Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc... Class I Hospira 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.
Sep 27, 2013 OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-US... Alcohol Prep Pads contained within the kit are not properly labeled. Class II Insulet Corporation
Sep 27, 2013 OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:... Alcohol Prep Pads contained within the kit are not properly labeled. Class II Insulet Corporation
Sep 16, 2013 STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Produ... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-24... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalo... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Aug 12, 2013 Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th... Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration ... Class II Abbott Laboratories, Inc
Jul 23, 2013 DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L... Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un... Class II Microgenics Corp
May 28, 2013 STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC ... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO M... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 23, 2013 Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300.... Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Ad... Class II Abbott Medical Optics, Inc.
Apr 15, 2013 FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic ... AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Gluco... Class I Abbott Diabetes Care, Inc.
Mar 28, 2013 The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... Class III Abbott Molecular
Dec 20, 2012 AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with... Two production orders of these IOLs that contain mislabeled IOLs. Class II Abbott Medical Optics Inc (AMO)
Dec 18, 2012 ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali... Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative ... Class II Abbott Laboratories, Inc
Dec 12, 2012 Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) an... The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely dep... Class II Abbott Laboratories
Dec 4, 2012 Abbott m2000sp Instrument; an automated fluid handling system for performing ... An issue with the m2000sp Instrument software has been identified whereby, after a series of step... Class II Abbott Molecular
Nov 16, 2012 Clinical Chemistry Phenobarbital, list number 1E08 Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773... Class II Abbott Laboratories, Inc
Nov 1, 2012 Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I ... APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect bar... Class II Abbott Point of Care Canada Limited
Aug 20, 2012 Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation ... Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have disco... Class II Abbott Vascular
Jul 19, 2012 Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06... Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control ... Class III Abbott Point Of Care Inc.
May 30, 2012 ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (... The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Ab... Class II Abbott Laboratories
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.
Mar 1, 2012 I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA... The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. Class II Abbott Point Of Care Inc.
Feb 1, 2012 i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test i... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Feb 1, 2012 i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Feb 1, 2012 i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is a... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Jan 31, 2012 Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up t... In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modify... Class II Abbott Molecular
Nov 30, 2011 Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS... The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX... Class II Abbott Vascular
Sep 8, 2011 iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The ... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 ... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, N... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 2... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. T... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Jan 1, 2011 I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 ... i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when... 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.