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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2015 | Merge RadSuite software. The firm name on the label is Merge Healthcare, Har... | The values provided from the Pixel Value tool do not appear to be correct, which may result in po... | Class II | Merge Healthcare, Inc. |
| Nov 11, 2015 | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.... | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Q... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Nov 10, 2015 | Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a m... | The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image... | Class II | Shimadzu Medical Systems |
| Nov 3, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer applicati... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Oct 29, 2015 | Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device Th... | A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolv... | Class II | Zimmer Biomet, 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 29, 2015 | Brilliance 64 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 SP 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 - Model no. NX1000-3. For home hemodialysis. | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c... | Class II | NxStage Medical, Inc. |
| Oct 29, 2015 | Ingenuity Core 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 - Model no. NX1000-3-A (OUS). For home hemodia... | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c... | Class II | NxStage Medical, Inc. |
| Oct 29, 2015 | NxStage System One S Cycler -High Permeability Hemodialysis System Model no... | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may co... | Class II | NxStage Medical, Inc. |
| 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 |
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.