Browse Device Recalls

3,235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,235 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 3,235 FDA device recalls.

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DateProductReasonClassFirm
Oct 9, 2018 BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2... This recall has been initiated due to a software defect found in the Guide System software when u... Class I Synaptive Medical Inc
Oct 3, 2018 Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... Class II Medtronic Inc.
Oct 2, 2018 Medtronic CareLink 2090 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual wit... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 2, 2018 Medtronic CareLink Encore 29901 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual wit... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 1, 2018 C3 Wave App, v. 2.0.5 When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Up... Class II Medical Components, Inc dba MedComp
Sep 28, 2018 Tosoh AIA-900 immunoassay Analyzer A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to... Class II Tosoh Bioscience Inc
Sep 26, 2018 Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specim... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens ... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens.... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens ... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View usin... Class I Medtronic Navigation, Inc.
Sep 24, 2018 Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo... Class II Invivo Corporation
Sep 24, 2018 PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fi... Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3... Class II PerkinElmer Health Sciences Canada, Inc.
Sep 21, 2018 RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, ... Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5... Class II RAYSEARCH LABORATORIES AB
Sep 20, 2018 AS-OBGYN Information System version 7.824.x Any change made to current ultrasound machine software or hardware upgrades, adding or modifying ... Class II AS Software, Inc.
Sep 19, 2018 Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System ... Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts af... Class II Philips Medical Systems Gmbh, DMC
Sep 18, 2018 Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... Class I COVIDIEN LLC
Sep 18, 2018 SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 If an operator attempts to manually program a Basic Infusion for a drug that is not included in t... Class II Baxter Healthcare Corporation
Sep 17, 2018 Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and... Class II Medtronic Navigation, Inc.-Littleton
Sep 17, 2018 Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc... Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The comp... Class II Beckman Coulter Inc.
Sep 13, 2018 Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#:... The service manual was not updated at the time of the release of software version 1.30. Class II Terumo Cardiovascular Systems Corporation
Sep 10, 2018 Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Sci... There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber sti... Class II Boston Scientific Corporation
Sep 4, 2018 Neuro Omega System, incorporating HaGuide software. For neurological and n... If cables are improperly connected, current may reach high charge density, causing tissue harm. Class I Alpha Omega Engineering
Sep 4, 2018 Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... Software Correction: Software errors that may result in incorrect 4D CT images, PET images with S... Class II Philips Medical Systems (Cleveland) Inc
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 29, 2018 IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software p... Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) ins... Class II Data Innovations, LLC
Aug 28, 2018 VidiStar(TM) PACS & DICOM Viewer Software system The secure filesystem client software used in the interface between the Vidistar PACS and an EHR ... Class II Hitachi Healthcare Americas Corp Informatics Di...
Aug 15, 2018 MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple ... When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound T... Class II Agilent Technologies, Inc.
Aug 13, 2018 VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Entero... Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... Class II bioMerieux, Inc.
Aug 13, 2018 VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Entero... Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... Class II bioMerieux, Inc.
Aug 3, 2018 Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Versio... Released with an incorrect, older firmware version installed. May result in intermittent loss of... Class II Invivo Corporation
Aug 1, 2018 Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ... Class II ICU Medical Inc
Aug 1, 2018 AIRO Mobile CT System Model # MobiCT-32 The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with softwar... Class II Mobius Imaging, LLC
Jul 26, 2018 Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: H... When creating a correction plan with the Correct Axial First button selected and the No. of cor... Class II Stryker GmbH
Jul 23, 2018 Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On ... There is a software issue that can potentially impact sample identification and traceability unde... Class II Tecan US, Inc.
Jul 13, 2018 G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... Analyzers were distributed with software which lacks a 510K Class II Tosoh Bioscience Inc
Jul 11, 2018 Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while... Class I Spacelabs Healthcare, Ltd.
Jul 3, 2018 ABL800 analyzer, model numbers 393-800 and 393-801. The analyzer software may cause a mis-match of patient demographics and test results when a certa... Class II Radiometer America Inc
Jul 2, 2018 iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic ... The device and its accessories may not have been manufactured according to current Good Manufactu... Class II Hudson Scientific LLC
Jun 29, 2018 Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... Class II Luminex Corporation

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.