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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.