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Browse Device Recalls

96 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 96 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 96 FDA device recalls.

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DateProductReasonClassFirm
Nov 13, 2025 Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun... Class II Abbott Laboratories
Sep 18, 2025 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... Class II Abbott Laboratories
Mar 18, 2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... When expired reagents are scanned or manually entered, the system will change the expiration date... Class II Abbott Laboratories
Mar 18, 2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... When expired reagents are scanned or manually entered, the system will change the expiration date... Class II Abbott Laboratories
Mar 18, 2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... When expired reagents are scanned or manually entered, the system will change the expiration date... Class II Abbott Laboratories
Mar 18, 2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... When expired reagents are scanned or manually entered, the system will change the expiration date... Class II Abbott Laboratories
Mar 18, 2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... When expired reagents are scanned or manually entered, the system will change the expiration date... Class II Abbott Laboratories
Jun 14, 2024 Alinity hq Analyzer, REF: 09P68-01 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... Class II Abbott Laboratories
Feb 21, 2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturi... Class II Abbott Laboratories
Oct 19, 2023 ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
May 30, 2023 Alinity ci-series System Control Module, REF: 03R70-01 There are potential performance issues found in the Alinity ci-series System software versions 3.... Class II Abbott Laboratories
Nov 24, 2022 Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI... Reaction vessels may contain a potential contaminant that could affect their optical performance. Class III Abbott Laboratories
Jul 26, 2022 ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking age... Class II Abbott Laboratories
Jun 9, 2022 REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 9, 2022 REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 9, 2022 REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
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
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
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
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)
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
May 24, 2019 ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 24, 2019 ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 22, 2019 "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR... Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The ma... Class II Abbott Laboratories
May 9, 2019 Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner an... Class II Abbott Laboratories
May 1, 2019 ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy... Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result ... Class II Abbott Laboratories, Inc
Apr 9, 2019 ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHIT... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR... Devices were delivered without the required dry ice. Class III Abbott Laboratories

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.