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Browse Device Recalls

28 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 28 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 28 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 21, 2025 i-STAT EG7+ cartridge. List Number: 03P76-25. Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... Class II Abbott Point Of Care Inc.
Aug 21, 2025 i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K... Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... Class II Abbott Point Of Care Inc.
Aug 21, 2025 i-STAT CG4+ cartridge (white). List Number: 03P85-25. Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type... Class II Abbott Point Of Care Inc.
Aug 21, 2025 i-STAT EG6+ cartridge. List Number: 03P77-25. Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... Class II Abbott Point Of Care Inc.
Dec 22, 2020 Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement ... Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep... Class II Abbott Point Of Care Inc.
Dec 22, 2020 Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of ... Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep... Class II Abbott Point Of Care Inc.
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.
Oct 16, 2019 i-STAT cTnI cartridge i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. T... Class II Abbott Point Of Care Inc.
Sep 13, 2018 Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification... Inaccurate potassium results may be generated. When testing with control fluid and/or patient sam... Class II Abbott Point Of Care Inc.
Sep 12, 2017 i-STAT DE handheld data processing module for clinical use, Software Version ... Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lis... Class II Abbott Point Of Care Inc.
Jun 15, 2015 i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged ... Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs p... Class II Abbott Point Of Care Inc.
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.
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.
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.
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.
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.