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
Feb 1, 2021 Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Due to software defect, under certain assay parameters, false Vitamin D results may be reported. ... Class II Thermo Fisher Scientific
Jan 28, 2021 VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the ext... bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... Class II Biomerieux Inc
Jan 28, 2021 VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with... bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... Class II Biomerieux Inc
Jan 27, 2021 Sensis / Sensis Vibe systems with software version VD12 and equipped with HP ... System may sporadically freeze (lock-up) during operation or while being in an idle state, no lon... Class II Siemens Medical Solutions USA, Inc
Jan 22, 2021 Radiation therapy software, RayStation standalone software treatment planning... A software bug affecting results when using deep learning (DL) segmentation followed by geometric... Class II RaySearch America Inc
Jan 5, 2021 Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... Users cannot complete testing due to a sign-error in the software component that controls the fil... Class III Biomeme, Inc.
Dec 24, 2020 PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgra... Patient tabletop moved out to the home position during scan initialization, may cause operator/by... Class II Philips North America
Dec 22, 2020 The EOSedge system may acquire two simultaneous orthogonal planar images for ... Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been... Class II EOS Imaging
Dec 18, 2020 ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 ... Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or A... Class II Siemens Medical Solutions USA, Inc
Dec 17, 2020 A calculator/data processing module for clinical use is an electronic device ... A software error results in the unintentional removal of the serum-indices flag that would otherw... Class II Roche Diagnostics Operations, Inc.
Dec 14, 2020 Neuroreader Medical Image Processing Software - Product Usage: intended to au... The Neuroreader has been distributed with a reference normative database that is different from ... Class II Brainreader ApS
Dec 11, 2020 FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... The software does not update measurements and calculations in the Clinical Reporting Application ... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 7, 2020 IOLMaster 700 When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient ... Class II Carl Zeiss Meditec AG
Dec 2, 2020 Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens... Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... Class II Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020 Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens.... Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... Class II Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020 Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens... Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... Class II Siemens Healthcare Diagnostics, Inc.
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usa... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871... When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t... Class II Roche Molecular Systems, Inc.
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 20, 2020 Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref ... Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered b... Class II Haag-Streit USA Inc
Nov 20, 2020 VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020 enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 19, 2020 Emission Computed Tomography System Image Process System - Product Usage: int... A software defect that has the potential to result in image misdiagnosis and incorrect treatment ... Class II Philips North America, LLC
Nov 19, 2020 The cobas z 480 analyzer including dedicated software for IVD use is a plate-... Dirty Lens May Cause Invalid or False Positive Results Class II Roche Molecular Systems, Inc.
Nov 19, 2020 Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... A software anomaly in the A620 Patient Programmer application was identified that results in fail... Class II Medtronic Neuromodulation
Nov 18, 2020 Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 17, 2020 Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.... A software error was detected within software version 1.3.4 for the Tempus LS device. When exitin... Class II Remote Diagnostic Technologies Ltd.
Nov 16, 2020 Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer... Class II Covidien Llc
Nov 12, 2020 Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Progra... A710 Intellis Clinician Application has a software issue that can result in the inability to prog... Class II Medtronic Neuromodulation
Nov 12, 2020 CareLink Personal Software Therapy Management Software Tool for Diabetes Car... Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... Class II Medtronic Inc.
Nov 11, 2020 Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A A software problem has been identified which could result in the diagnostic imaging system not p... Class II Canon Medical System, USA, INC.
Nov 9, 2020 Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product... A software problem has been identified which could result in the CT Scanner not proceeding to th... Class II Canon Medical System, USA, INC.
Nov 9, 2020 icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... Due to a potential software issue, the display may show the incorrect continuous cardiac output (... Class II ICU Medical, Inc.
Nov 3, 2020 Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed o... It has been determined that the software distributed with the retinal camera may delete patient i... Class II Kowa Optimed Inc
Oct 27, 2020 All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, E... The manufacturer has determined that with certain uncommon workflows there is potential for incor... Class II Philips Ultrasound Inc
Oct 23, 2020 The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnost... The firm has become aware of nine reports by a single customer that the software made false posit... Class II Biomeme, Inc.
Oct 23, 2020 Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Softw... Stryker has discovered a characterization issue associated with the Mako Integrated Cutting Syste... Class II Mako Surgical Corporation
Oct 9, 2020 cobas infinity central lab/cobas infinity core license-The cobas infinity IT ... Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expira... Class II Roche Diagnostics Operations, Inc.
Oct 8, 2020 RayStation standalone software treatment planning system, Model No. 4.0, 4.5,... If a region of interest (ROI) or point of interest (POI) that is referenced from an imported pla... Class II RAYSEARCH LABORATORIES AB
Sep 28, 2020 VNS Therapy¿ AspireSR¿ Generator Due to an extra digit being inadvertently added to the serial number of a subset of implantable p... Class II LivaNova USA Inc
Sep 22, 2020 9310HD Digital Video Capture Module with software version 3.4.0 or higher con... There is an intermittent software issue that could affect the systems, in which an exam video for... Class II Pentax of America Inc
Sep 22, 2020 Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSI... There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in ... Class II Boston Scientific Corporation
Sep 22, 2020 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), There is an intermittent software issue that could affect the systems, in which an exam video for... Class II Pentax of America Inc
Sep 18, 2020 ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intende... There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Ph... Class II Siemens Medical Solutions USA, Inc
Sep 12, 2020 Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR18... The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked... Class II Fresenius Medical Care Holdings, Inc.
Sep 11, 2020 Synapse PACS Software Versions 5.1 and higher There is a potential for the wrong patient information may be displayed in the viewer or PowerJac... Class II Fujifilm Medical Systems U.S.A., 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.