Browse Device Recalls

3,007 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,007 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 3,007 FDA device recalls.

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DateProductReasonClassFirm
Aug 31, 2022 MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Software calibration error with product equip with a Dose Area Product (DAP) meter. This results... Class II Micro-X Ltd.
Aug 26, 2022 Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. ... During internal testing, Leica Microsystems has become aware of a component change on the photodi... Class II Leica Microsystems, Inc.
Aug 26, 2022 Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 During internal testing, Leica Microsystems has become aware of a component change on the photodi... Class II Leica Microsystems, Inc.
Aug 26, 2022 Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 During internal testing, Leica Microsystems has become aware of a component change on the photodi... Class II Leica Microsystems, Inc.
Aug 26, 2022 Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 During internal testing, Leica Microsystems has become aware of a component change on the photodi... Class II Leica Microsystems, Inc.
Jul 27, 2022 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute a... (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, ha... Class II Fresenius Medical Care Holdings, Inc.
Jul 21, 2022 TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen ... Class I Cardiac Assist, Inc
Jul 19, 2022 NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... Class III NuVasive Inc
Jul 14, 2022 cobas e801 Immunoassay Analyzer Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2022 Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... Class II Aesculap Implant Systems LLC
Jul 13, 2022 VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... There are 7 reported software anomalies that may affect use of the device. Class II bioMerieux, Inc.
Jul 12, 2022 Surpria: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... Class II FUJIFILM Healthcare Americas Corporation
Jul 12, 2022 SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... Class II FUJIFILM Healthcare Americas Corporation
Jul 12, 2022 Surpria 64: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... Class II FUJIFILM Healthcare Americas Corporation
Jul 8, 2022 Pentacam HR REF 70900. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 7, 2022 The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 5, 2022 ZAP-X Radiosurgery System Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... Class II Zap Surgical Systems
Jun 23, 2022 INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) ... The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible ... Class II Mallinckrodt, LLC.
Jun 23, 2022 Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and an... A race condition between the storage system and services database has the potential to revert edi... Class II DICOM Grid, Inc. d/b/a Ambra Health
Jun 22, 2022 ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: ... There is a potential risk of medication error when using specific Abacus Order Entry & Calculatio... Class I Baxter Healthcare Corporation
Jun 17, 2022 Merlin.net model MN5000 Software The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022 Merlin PCS 3650 programmer Model 3330 software There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022 Merlin 2 PCS MER37000 programmer Model MER3400 software The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 16, 2022 nordicBrainEX, software versions 2.21 through 2.3.10 When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both th... Class II NordicNeuroLab AS
Jun 15, 2022 Sensis Vibe Combo with software version VD12A. A diagnostic and administrati... Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... Class II Siemens Medical Solutions USA, Inc
Jun 15, 2022 Sensis with software version VD12A. A diagnostic and administrative tool su... Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... Class II Siemens Medical Solutions USA, Inc
Jun 15, 2022 SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge t... Class II Stryker Instruments Div. of Stryker Corporation
Jun 14, 2022 Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and ... Class II SIGHT DIAGNOSTICS LTD
Jun 14, 2022 Centricity PACS Software Version 7.0 SP0.0.4.7 The Event Notification Manager (ENM) functionality for certain products does not process notifica... Class II GE Healthcare, LLC
Jun 2, 2022 Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into... Class II Breas Medical, Inc.
May 31, 2022 NaviCare Nurse Call/Voalte Nurse Call An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, C... Class II Baxter Healthcare Corporation
May 31, 2022 Xhibit Telemetry Receiver, Model: 96280 Software related alarm escalation defect occurs after approximately 25 days of continuous use. Te... Class II Spacelabs Healthcare, Inc.
May 24, 2022 t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... Class II Tandem Diabetes Care Inc
May 24, 2022 BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with ... The automated dispensing cabinet software update included a .dll file that is not compatible with... Class II CareFusion 303, Inc.
May 24, 2022 t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... Class II Tandem Diabetes Care Inc
May 3, 2022 NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Software anomaly was identified. Class II Medtronic Xomed, Inc.
May 3, 2022 NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Software anomaly was identified. Class II Medtronic Xomed, Inc.
Apr 26, 2022 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... Class II Daavlin Distributing Company
Apr 26, 2022 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... Class II Daavlin Distributing Company
Apr 25, 2022 CardioTek EP-TRACER Software V2.x. Device did not pass electrical safety testing for adequate insulation. Class II CardioTek BV
Apr 22, 2022 Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed t... Class II Fresenius Kabi USA, LLC
Apr 21, 2022 ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1... Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may... Class II Dain Technology, Inc. (Subsidiary of Soundable ...
Apr 19, 2022 Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software ... When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or... Class II Haemonetics Corporation
Apr 18, 2022 Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... Class I Smiths Medical ASD Inc.
Apr 13, 2022 Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 ... Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis L... Class II Siemens Medical Solutions USA, Inc
Apr 12, 2022 Cobalt Models loaded with CareLink SmartSync Device Manager application softw... Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...

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.