Browse Device Recalls
3,099 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,099 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 3,099 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 15, 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Inte... | Due to Operator Console software anomaly, a change in treatment completion status of the last pat... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Dec 14, 2015 | BD Viper LT software, version 3.00H | BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper ... | Class II | Bd Diagnostic |
| Dec 10, 2015 | Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Co... | Due to a malfunction of software, the secondary module will not automatically take over messaging... | Class II | Ascom US, INC. |
| Dec 9, 2015 | Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: ... | Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow dire... | Class II | Philips Ultrasound, Inc. |
| Dec 7, 2015 | GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. | GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ... | Class II | GE Medical Systems, LLC |
| Dec 1, 2015 | UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Pa... | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN... | The firm became aware of cases in which the battery run times of the optional PS 500 power supply... | Class I | Draeger Medical, Inc. |
| Dec 1, 2015 | UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... | Class II | Beckman Coulter Inc. |
| Nov 25, 2015 | ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the ap... | There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C... | Class II | KCI USA, INC. |
| Nov 23, 2015 | The ZYTO Tower is the input device to program the software with various virtu... | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite S... | Class II | ZYTO Technologies, Inc. |
| Nov 23, 2015 | The ZYTO Select and ZYTO Elite software programs are used to rank pairs of ga... | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite S... | Class II | ZYTO Technologies, Inc. |
| Nov 18, 2015 | Software version VD10E for Syngo X-Workplace; Picture archiving and communica... | Potential post-processing software issue when using tabcard "4D" on X-Workplace with software ver... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 17, 2015 | Syngo Imaging XS is a Picture Archiving and Communication System (PACS) | For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in inco... | Class II | Siemens Medical Solutions USA, Inc |
| 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. |
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.