Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 29, 2015 | Ingenuity Core 128 Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Brilliance iCT Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Ingenuity CT Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no... | Ultrafiltration (UF) Volume software error inaccurate fluid removal | Class II | NxStage Medical, Inc. |
| Oct 28, 2015 | Syngo Imaging VB36D_HF02. Radiological image processing system. | To provide supplementary information regarding the release of the syngo Imaging Software Version ... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 27, 2015 | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ... | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain t... | Class II | Carl Zeiss Meditec AG |
| Oct 27, 2015 | IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 ... | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain t... | Class II | Carl Zeiss Meditec AG |
| Oct 26, 2015 | Merge Cardio with software version 10.1 LA. | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer... | Class II | Merge Healthcare, Inc. |
| Oct 26, 2015 | Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named Hear... | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer... | Class II | Merge Healthcare, Inc. |
| Oct 23, 2015 | iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart... | A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall.... | Class II | Otto Bock Healthcare GmbH |
| Oct 15, 2015 | DR Systems Unity PACS software, now known as Merge Unity PACS software. | The software fails to associate to the correct MG image if there are two images for the same view. | Class II | Merge Healthcare, Inc. |
| Oct 14, 2015 | Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,... | The following MRx software issue has been identified: MRx model M3535A with software version F.03... | Class II | Philips Electronics North America Corporation |
| Oct 8, 2015 | Merge OrthoCase software. The firm name on the label is Merge Healthcare, H... | Measurements in the software are changing after saving a plan with a measurement result, which ma... | Class II | Merge Healthcare, Inc. |
| Oct 7, 2015 | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that pro... | Siemens will provide all customers a new version of system software (VA35E or VB10C depending on ... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 7, 2015 | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical... | Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 1, 2015 | Merge Cardio software. Merge Cardio is a system intended to be used to ac... | Reporting feature times out after inactivity for more than an hour sending the user back to the s... | Class II | Merge Healthcare, Inc. |
| Sep 28, 2015 | ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assess... | An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessmen... | Class II | Varian Medical Systems, Inc. |
| Sep 22, 2015 | Merge Cardio software. Product Usage: Merge Cardio is a system intended... | Users can merge a device import file with an image study that already has a confirmed report, whi... | Class II | Merge Healthcare, Inc. |
| Sep 22, 2015 | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the... | For sites using the Issuer of Patient ID (IPID), the system will display the study list and image... | Class II | Merge Healthcare, Inc. |
| Sep 21, 2015 | Digital Lightbox, BrainLAB system, image processing, radiological Product ... | Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. | Class II | Brainlab AG |
| Sep 11, 2015 | NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d... | When using the NicoletOne v5.94 software, after exiting the impedance check function and returnin... | Class II | Natus Neurology Inc |
| Sep 10, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versio... | Class II | Ortho-Clinical Diagnostics |
| Sep 6, 2015 | Philips Healthcare Ingenuity CT Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity Core Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 6, 2015 | Philips Healthcare Brilliance iCT Computed Tomography X-Ray System | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... | Class II | Philips Healthcare |
| Sep 5, 2015 | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: ... | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON ... | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 3, 2015 | AMSCO 400 and AMSCO C Small Steam Sterilizers | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadver... | Class III | Steris Corporation |
| Sep 3, 2015 | Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC s... | under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack c... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 1, 2015 | IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IM... | Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not produc... | Class II | AGFA Healthcare Corp. |
| Aug 26, 2015 | syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a cl... | Software Issues. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 19, 2015 | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Mode... | The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 18, 2015 | SOMATOM Force; computed tomography x-ray system. Intended to generate and ... | Software and firmware bugs | Class II | Siemens Medical Solutions USA, Inc |
| Aug 17, 2015 | da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 ... | Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System ... | Class II | Intuitive Surgical, Inc. |
| Aug 14, 2015 | SOMATOM Definition Flash; intended to produce cross-sectional images of the b... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition AS, intended to produce cross-sectional images of the body... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition Edge; intended to produce cross-sectional images of the bo... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems | When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose m... | Class II | Toshiba American Medical Systems Inc |
| Aug 11, 2015 | Syngo RT Oncologist, an optional accessory to the linear accelerator system a... | This update is intended to provide a software update for the Syngo RT Oncologist, which is curren... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 11, 2015 | Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PA... | Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... | Class II | GE Healthcare |
| Aug 11, 2015 | Centricity Universal Viewer Product Usage: The Centricity Universal Viewe... | Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... | Class II | GE Healthcare |
| Aug 7, 2015 | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a per... | Software defect that impacts image alignment when using the automatic stitching option for long l... | Class II | Carestream Health Inc |
| Aug 7, 2015 | CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line moni... | Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a ... | Class II | Terumo Cardiovascular Systems Corporation |
| Aug 5, 2015 | ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, P... | A software fix has been released to prevent automatic movement resulting in a collision safety ri... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 4, 2015 | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilize... | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional Ne... | Class II | Bayer Healthcare |
| Jul 29, 2015 | Software version 4.44A utilized on the BD MAX System | The BD MAX System software version 4.44A contains a software anomaly that has the potential to af... | Class II | BD LIFE SCIENCES |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to m... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems 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.