Browse Device Recalls
3,089 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,089 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 3,089 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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| BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the p...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18, 2025 | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the p...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 |
| Jan 15, 2025 | MOSAIQ Oncology Information System | Image offsets calculated by oncology Information System software may be incorrect for Linear A... | Class II | Elekta, Inc. |
| Jan 10, 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... | Automated dispensing device labeling is being updated to strengthen labeling around manual access... | Class II | CareFusion 303, Inc. |
| Jan 10, 2025 | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected... | Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing t... | Class II | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO.... |
| Jan 10, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... | Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: ... | Class I | Fresenius Kabi USA, LLC |
| Jan 10, 2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... | Potential that the induction seal is not completely sealed to the device tube packaging. | Class II | Integra LifeSciences Corp. |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Jan 8, 2025 | (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... | Software issues could potentially result in: 1) delays in accessing dispensing software applicati... | Class II | CareFusion 303, Inc. |
| Jan 6, 2025 | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Ca... | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omiss... | Class II | Sysmex America, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Dec 20, 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-... | Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). | Class II | Integrity Implants Inc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... | The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the S... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... | The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if th... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 18, 2024 | Monitoring Service Application (MSA). Software to process, analyze, display, ... | Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and ... | Class I | Braemar Manufacturing, LLC |
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.