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Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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DateProductReasonClassFirm
Feb 25, 2025 Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Stationary column TruSystem 7500 U, Product Code 1730731 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Stationary column TruSystem 7500, Product Code 1717020 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500, Product Code 4091000 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Mobile column TruSystem 7500 U, Product Code 1730720 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 MIM software; System, Image Processing, Radiological In situations where two images with differing Fields of View (FOV) complete an image fusion, an i... Class II MIM Software Inc
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: ... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: ... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 18, 2025 BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 18, 2025 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 11, 2025 Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4... The incorrect computed patient age is showing in VX for patients less than 3 months old. Class II FUJIFILM Healthcare Americas Corporation
Feb 10, 2025 Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 Under certain circumstances, it can occur that patient records from unrelated individuals are aut... Class II Brainlab AG
Feb 6, 2025 BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... Sync timeout may occur between the server and automated dispensing device, due to a server softwa... Class II CareFusion 303, Inc.
Feb 5, 2025 IntelePACS (Image Fusion Module) - InteleViewer A software application that receives digital images and data from various sources has a bug in sp... Class II INTELERAD MEDICAL SYSTEMS INCORPORATED
Feb 5, 2025 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... There is the potential for missing motor mounting screws, which may have occurred during the serv... Class I Baxter Healthcare Corporation
Feb 3, 2025 Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS i... Potential variability in calculations from fast array scans compared to array scans when operatin... Class II Medimaps Group
Jan 31, 2025 Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Cat... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Jan 31, 2025 Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Jan 30, 2025 Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog N... Firm became aware of software issues related to most recent firmware update which could result in... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Jan 24, 2025 Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device M... Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... Class II Guangzhou Pluslife Biotech Co., Ltd.
Jan 24, 2025 Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid T... Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... Class II Guangzhou Pluslife Biotech Co., Ltd.
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sen... Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming pr... Class II Spectrum Medical Inc
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 15, 2025 Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model... Devices presented a condition in which the inner needle separated from the hub and produced a lon... Class II Hologic, 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.