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
Mar 13, 2024 Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 13, 2024 Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: E... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 11, 2024 OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... System error messages may delay the ability to test patient samples and the need for frequent cal... Class II Advanced Instruments, LLC
Mar 7, 2024 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... Class I Fresenius Kabi USA, LLC
Feb 28, 2024 Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX ... It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... Class II Philips North America
Feb 28, 2024 CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent... It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... Class II Philips North America
Feb 27, 2024 CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... Class I Smiths Medical ASD Inc.
Feb 23, 2024 ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Junipe... On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... Class II Siemens Medical Solutions USA, Inc.
Feb 23, 2024 RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si,... Class II RAYSEARCH LABORATORIES AB
Feb 23, 2024 ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select... On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... Class II Siemens Medical Solutions USA, Inc.
Feb 23, 2024 ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running softw... On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... Class II Siemens Medical Solutions USA, Inc.
Feb 8, 2024 microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 11... Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated thi... Class II Landauer
Feb 8, 2024 Software VERIQA (S070031), version 2.0 and 2.1- Software package for display,... Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold ... Class II PTW-FREIBURG
Feb 7, 2024 Torrent Suite Dx Software versions 5.14 and earlier used in connection with I... Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems ex... Class II Life Technologies Corporation
Feb 1, 2024 BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStatio... Automated dispensing cabinets, running affected software, and Windows 10 operating system may exp... Class II CareFusion 303, Inc.
Jan 26, 2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS XT 7600 Integrated System, Catalog No. 6844461 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS XT 7600 Integrated System, Catalog No. 6844461 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 3, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... A software error caused an increase in tray gripper motion errors that causes intermittent hard s... Class II Beckman Coulter, Inc.
Jan 3, 2024 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... Due to software and controller systems that results in unexpected pump start or pump stop. Class I Thoratec Corp.
Dec 27, 2023 Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately Class II TruAbutment Inc.
Dec 22, 2023 Baxter Exactamix Pro 2400, REF EXM24DY An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... Class I Baxter Healthcare Corporation
Dec 22, 2023 Baxter Exactamix Pro 1200, REF EXM12DY An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... Class I Baxter Healthcare Corporation
Dec 20, 2023 Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... Class II Zyno Medical LLC
Dec 19, 2023 smiths medical Medfusion Model 4000 syringe pump Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... Class I Smiths Medical ASD Inc.
Dec 19, 2023 smiths medical Medfusion Model 3500 Syringe pump Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... Class I Smiths Medical ASD Inc.
Dec 13, 2023 Spectral CT on Rails: Software Version 5.1.0.X, model 728334. A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 13, 2023 Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023 WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Deskto... Following an FDA-issued Warning Letter, the firm requested return of their research EEG system co... Class II WAVi Co.
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 6, 2023 Impella Connect, software portal for online device management that allows cli... The following features have been disabled from the web-based portal because the FDA has not evalu... Class II Abiomed, Inc.
Nov 30, 2023 Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. Multiple software issues that affect device functionality. Class II Philips North America Llc
Nov 30, 2023 Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... Class II Boston Scientific Corporation
Nov 30, 2023 Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.... The bolus calculator is not recording the decimal point if it is the first value entered when cha... Class I Insulet Corporation
Nov 21, 2023 DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... Class II Beckman Coulter, Inc.
Nov 16, 2023 Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... Due to software issue, New systems may exhibit an error which may prohibit use of new systems res... Class II Covidien
Nov 15, 2023 The device is an X-ray system that is capable of radiographic and fluoroscopi... VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... Class II Canon Medical System, USA, INC.
Nov 1, 2023 Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... Class II Turncare, Inc
Oct 19, 2023 epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... Class II Siemens Healthcare Diagnostics Inc
Oct 18, 2023 Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Their is the potential that software issues may result in flipped image of the virtual Bronchosc... Class II AURIS HEALTH INC
Oct 18, 2023 Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w Their is the potential that software issues may result in flipped image of the virtual Bronchosc... Class II AURIS HEALTH INC
Oct 18, 2023 Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w Their is the potential that software issues may result in flipped image of the virtual Bronchosc... Class II AURIS HEALTH 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.