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 |
|---|---|---|---|---|
| Mar 25, 2016 | EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi syst... | Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software... | Class II | Intuitive Surgical, Inc. |
| Mar 24, 2016 | Ingenuity Core Computed Tomography X-ray systems is intended to produce cross... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body comput... | The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version... | Class II | Philips and Neusoft Medical Systems Co., Ltd. |
| Mar 24, 2016 | Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produ... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to p... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce c... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to pr... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Dimension Vista 1500 Intelligent Lab System running on software versions V.3.... | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... | Class II | Siemens Healthcare Diagnostics Inc. |
| Mar 24, 2016 | Dimension Vista 500 Intelligent Lab System running on software versions V.3.6... | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... | Class II | Siemens Healthcare Diagnostics Inc. |
| Mar 21, 2016 | SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model nu... | The affected scanner does not correctly interact with the SC360 software. When docked pre/postope... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 17, 2016 | enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... | The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... | Class II | Ortho-Clinical Diagnostics |
| Mar 16, 2016 | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0... | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database th... | Class II | Optovue, Inc. |
| Mar 10, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ... | Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 10, 2016 | eCareCoordinator allows the customer to schedule patient tasks (i.e., take we... | The adherence check generates a software error. Two issues occur as a result of the software err... | Class II | Philips Visicu |
| Mar 10, 2016 | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a m... | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the anal... | Class II | Merge Healthcare, Inc. |
| Mar 9, 2016 | Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog numbe... | After performing the suctioning maneuver, including disconnecting the patient, suctioning , and r... | Class II | Hamilton Medical, Inc. |
| Mar 7, 2016 | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Deli... | When editing the isocenter or the couch position of the plan while in the treatment workflow (in ... | Class II | Viewray Incorporated |
| Mar 4, 2016 | Extended Brilliance Workspace NM Nuclear medicine image display and processin... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 4, 2016 | Extended Brilliance Workspace NM Special Nuclear medicine image display and p... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 4, 2016 | IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medi... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images ... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of ... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash a... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition: Intended to produce cross-sectional images of the... | Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients wit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 24, 2016 | Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, a... | During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS ex... | Class II | Toshiba American Medical Systems Inc |
| Feb 24, 2016 | VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Ca... | Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. a... | Class II | Biomerieux Inc |
| Feb 24, 2016 | Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume... | Wrong quantitative results may be displayed in a report from the device, which may potentially le... | Class II | Ab Sciex |
| Feb 19, 2016 | CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... | Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... | Class II | Medtronic MiniMed Inc. |
| Feb 19, 2016 | Cios Alpha, mobile X-ray system | Software issues on Cios Alpha mobile C-Arm system | Class II | Siemens Medical Solutions USA, Inc |
| Feb 11, 2016 | MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 ... | Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software... | Class II | Beckman Coulter Inc. |
| Feb 10, 2016 | RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4... | A software issue with editing tools that use the left mouse button held down, for drawing in and ... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 9, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | A report can be confirmed with the incorrect patient demographics resulting in it being saved und... | Class II | Merge Healthcare, Inc. |
| Feb 5, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., H... | When measuring a lesion on an unmagnified mammography image then performing the same measurement ... | Class II | Merge Healthcare, Inc. |
| Feb 5, 2016 | Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cros... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cr... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-s... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-se... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cro... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of product archiving not working properly. | Class II | Merge Healthcare, Inc. |
| Jan 31, 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down ... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge Cardio software. Product Usage: Merge Cardio is an integrated car... | Patient information in the header is only found on the first page of the report and not on the su... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | A migrated study that has annotations will display the annotations, but when a prior study is loa... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of the software archiving not working properly. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. Product was distributed under the AMICAS label, Brighto... | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Access used with Ortho PACS software provides medical specialists wi... | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not disp... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Access used with Merge PACS software provides medical specialists wi... | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not disp... | Class II | Merge Healthcare, 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.