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Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

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DateProductReasonClassFirm
Apr 28, 2025 Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a ... There were reports of an increase in reactive negative controls and false positive results. Class II Abbott Molecular, Inc.
Apr 28, 2025 Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time r... There were reports of an increase in reactive negative controls and false positive results. Class II Abbott Molecular, Inc.
Mar 20, 2025 The Alinity m System is designed to automate the steps for nucleic acid testi... The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or s... Class II Abbott Molecular, Inc.
Sep 12, 2024 Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: ... Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... Class II Abbott Molecular, Inc.
Sep 12, 2024 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: ... Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... Class II Abbott Molecular, Inc.
Mar 20, 2024 Alinity m System, Part Number: 08N53-002 The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and t... Class II Abbott Molecular, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Oct 30, 2023 Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. Th... Abbott has received reports of an increase in reactive negative controls and false positive resul... Class II Abbott Molecular, Inc.
Dec 9, 2022 Alinity m System. The Alinity m System is designed to automate the steps... The firm identified the following three potential issues which may have impacted ADUs installed o... Class II Abbott Molecular, Inc.
Nov 22, 2022 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 Reports of an increase in reactive negative controls and false positive results with certain lots... Class II Abbott Molecular, Inc.
Nov 22, 2022 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 Reports of an increase in reactive negative controls and false positive results with certain lots... Class II Abbott Molecular, Inc.
Nov 11, 2022 Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction U... The instrument was found to be installed without plunger assemblies in the clamp bar for an Ampli... Class II Abbott Molecular, Inc.
Oct 12, 2022 Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use Abbott has identified potential performance issues for the Alinity m System software version 1.6.... Class II Abbott Molecular, Inc.
Aug 19, 2022 Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1... Reports received of an increase of message code 9186 (internal control failed) when using the kit. Class II Abbott Molecular, Inc.
Jul 19, 2022 The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. Incorrect optical calibration Class II Abbott Molecular, Inc.
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.
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.
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.
Oct 23, 2014 Abbott m2000sp, an automated system for performing sample preparation for nuc... Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw... Class II Abbott Molecular
Jun 19, 2014 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Han... Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 569440... Class II Abbott Molecular
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
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 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
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

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.