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
Sep 18, 2019 iLab Polaris Multi-Modality Guidance System; iLab Ultraso... Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batc... Class II Boston Scientific Corporation
Sep 10, 2019 NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication... The firm received a report of an atypical dataset being generated. When using the cross-localizat... Class II Novarad Corporation
Aug 29, 2019 Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android sof... The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging... Class II LABSTYLE INNOVATIONS
Aug 26, 2019 Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, w... Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with th... Class II Shanghai United Imaging Healthcare Co., Ltd.
Aug 23, 2019 Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime... At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer la... Class II Ra Medical Systems, Inc.
Aug 12, 2019 Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 12... After a recent upgrade to the collimator software version 8.5, the firm became aware that the mul... Class II Varian Medical Systems, Inc.
Aug 9, 2019 Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... Class I Medtronic Navigation, Inc.
Aug 6, 2019 BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors... The device data being collected and transferred to the monitoring center may not be accurate due ... Class II Preventice Services, LLC
Jul 31, 2019 HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A... software error in the central control unit of the floor stand. Class II Haag-Streit USA Inc
Jul 31, 2019 HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A... software error in the central control unit of the floor stand. Class II Haag-Streit USA Inc
Jul 31, 2019 HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage... software error in the central control unit of the floor stand. Class II Haag-Streit USA Inc
Jul 30, 2019 Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ... Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.... Class II Siemens Healthcare Diagnostics, Inc.
Jul 26, 2019 BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing ... An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m... Class II Becton Dickinson & Co.
Jul 26, 2019 BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing ... An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m... Class II Becton Dickinson & Co.
Jul 25, 2019 syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomog... SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT ... Class II Siemens Medical Solutions USA, Inc
Jul 23, 2019 AggreGuide A-100 Instrument The firm identified a software design issue where the improper shut down of the instrument result... Class II Aggredyne, Inc.
Jul 23, 2019 Mammomat Revelation with software version VC10 and Biopsy Option Intended ... An error can occur when performing a biopsy using the InSpect function. The acquisition workstati... Class II Siemens Medical Solutions USA, Inc
Jul 22, 2019 Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof... Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error ... Class II Zeus Scientific, Inc.
Jul 18, 2019 IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Li... Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (... Class II Medical Intelligence Medizintechnik Gmbh
Jul 16, 2019 Philips Azurion systems with software version R1.2 -Interventional Fluorosc... The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to t... Class II Philips North America, LLC
Jul 12, 2019 Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing softw... It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 ... Class II Dexcom Inc
Jul 12, 2019 ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-00... Firm identified several software issues through internal testing of its Cogent Hemodynamic Monito... Class II ICU Medical, Inc.
Jul 10, 2019 ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Software Security; The action is being initiated because of software security vulnerabilities wi... Class II Radiometer America Inc
Jul 9, 2019 Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully i... code 7-102 Liquid Sensor Error Class II Phadia Ab
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 350 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encou... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 3, 2019 SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomograph... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of... Class II Elekta Inc
Jul 3, 2019 SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tom... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomo... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography sys... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography sys... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomogra... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 2, 2019 QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (T... QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate I... Class II Qiagen Sciences LLC
Jun 24, 2019 Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag... The QA software solution to perform the MR to MV alignment check, does not display the stored MR ... Class II Elekta, Inc.
Jun 24, 2019 VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1... The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... Class I Fenwal Inc
Jun 24, 2019 Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod... The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... Class I Fenwal 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.