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
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
Dec 13, 2024 Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 6, 2024 Portrait Core Services, a set of software services that enable the communicat... There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... Class II GE Medical Systems, LLC
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 3, 2024 UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW300... Due to software anomalies that may impact on rod planning specifically, certain optional surgical... Class II Medicrea International
Dec 2, 2024 Change Healthcare Cardiology Hemodynamics software Software defect concerning autosave mechanism may result in the clinician administering incorrect... Class II A L I Technologies Ltd
Dec 2, 2024 McKesson Cardiology Hemo software Software defect concerning autosave mechanism may result in the clinician administering incorrect... Class II A L I Technologies Ltd
Dec 2, 2024 Change Healthcare Cardiology Hemo software Software defect concerning autosave mechanism may result in the clinician administering incorrect... Class II A L I Technologies Ltd
Nov 26, 2024 Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 882... Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. Class II O&M HALYARD, INC.
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide mo... Telemetry receivers with affected software versions may experience unsolicited system shut down a... Class II Spacelabs Healthcare, Inc.
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 25, 2024 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... The probe tips of the hand instruments are being damaged or breaking including pad damage and det... Class II Olympus Corporation of the Americas
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Ver... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Versi... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 21, 2024 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... Software issues were identified in application version 2.x. Class II Medtronic Neuromodulation
Nov 21, 2024 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... Software issues were identified in application version 2.x. Class II Medtronic Neuromodulation

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.