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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
Mar 11, 2022 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019... Due to an increase in complaint trend for leaks and intermittent/loose connections. Class II Abbott Vascular
Mar 11, 2022 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) Due to an increase in complaint trend for leaks and intermittent/loose connections. Class II Abbott Vascular
Mar 11, 2022 INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) Due to an increase in complaint trend for leaks and intermittent/loose connections. Class II Abbott Vascular
Mar 11, 2022 Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Pl... Due to an increase in complaint trend for leaks and intermittent/loose connections. Class II Abbott Vascular
Mar 8, 2022 ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myogl... This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a cal... Class II Abbott Laboratories
Mar 4, 2022 Alinity m HBV Application Specification File (US and CE) There is a potential for misquantitation high results of negative samples. Class II Abbott Molecular, Inc.
Mar 4, 2022 Alinity m HBV AMP Kit (US and CE) There is a potential for misquantitation high results for negative samples. Class II Abbott Molecular, Inc.
Feb 11, 2022 Alinity m Integrated Reaction Units (IRU) There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by t... Class II Abbott Molecular, Inc.
Feb 3, 2022 Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash b... Class II Abbott Laboratories, Inc
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is an issue with the installation of updated camera firmware on the system. Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ... Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a software issue associated with the ability to properly complete a Field Service Engine... Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a potential for abnormal (non-sigmoidal) amplification curves. Class II Abbott Molecular, Inc.
Nov 16, 2021 Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was m... Class II Abbott
Nov 9, 2021 Amplatzer Steerable Delivery Sheath Instructions for use were updated. Class II Abbott
Oct 22, 2021 Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Re... If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-en... Class II Thoratec Corp.
Sep 29, 2021 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ... Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... Class II Abbott Laboratories
Sep 29, 2021 ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/... Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... Class II Abbott Laboratories
Sep 2, 2021 Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Ali... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alin... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Applic... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Aug 4, 2021 Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 Spectru... Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient sam... Class II Abbott Molecular, Inc.
Jul 26, 2021 Alinity ci-series System Control Module clinical chemistry and immunoassay an... Due to potential performance issues with software version 3.2.3 and earlier. Performance issues ... Class II Abbott Laboratories
Jul 12, 2021 Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vit... A design defect (hardware and software) allows liquid waste pressure to build up and potentially ... Class II Abbott Laboratories, Inc
Jun 10, 2021 REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 10, 2021 REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 10, 2021 REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Ki... There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples... Class II Abbott Laboratories
Jun 10, 2021 REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
May 5, 2021 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model... Due to a software error, the user may lose functionality of the system or the screen may turn bla... Class II Abbott Laboratories Inc. (St Jude Medical)
May 5, 2021 WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 Due to a software error, the user may lose functionality of the system or the screen may turn bla... Class II Abbott Laboratories Inc. (St Jude Medical)
May 5, 2021 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ... Due to a software error, the user may lose functionality of the system or the screen may turn bla... Class II Abbott Laboratories Inc. (St Jude Medical)
Apr 22, 2021 NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Potential capacitor failure which typically manifests as in inability to provide output on one or... Class II Abbott Laboratories Inc. (St Jude Medical)
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.
Jun 19, 2020 Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ... Quality Control results were not properly evaluated for QC failures. Class II Abbott Gmbh & Co. KG
May 22, 2020 TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 ... High rate of reported complaints for the loss of contact force information while using the TactiC... Class II Abbott
May 12, 2020 Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. There is a potential to generate incorrect patient results for the following assays: Alkaline Pho... Class II Abbott Gmbh & Co. KG
Apr 24, 2020 ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained ... Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High... Class II Abbott Gmbh & Co. KG
Apr 7, 2020 Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
Apr 7, 2020 Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA ... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 2, 2020 Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACC... In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Mo... Class II Abbott Laboratories
Apr 1, 2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories
Apr 1, 2020 ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis ... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories
Apr 1, 2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories
Mar 25, 2020 Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStr... Incorrect expiration date Class II Abbott Vascular
Mar 23, 2020 Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 11165... The analyzer system may have an electrostatic discharge and sparking of the power supply provided... Class II Abbott Diagnostics Technologies AS
Mar 9, 2020 ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading t... Class II Abbott Gmbh & Co. KG
Feb 28, 2020 Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... Internal testing of software identified software anomaly scenarios where if non-applicable shock ... Class II Abbott

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.