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 |
|---|---|---|---|---|
| Aug 20, 2013 | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or... | The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data fr... | Class III | Bio-Rad Laboratories |
| Aug 16, 2013 | Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... | Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 9, 2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... | The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... | Class III | Copan Italia |
| Aug 1, 2013 | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.... | Under certain circumstances, the Left eye image may be saved as the Right eye image. | Class II | Nidek Inc |
| Jul 26, 2013 | DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY... | During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an a... | Class II | Carestream Health, Inc. |
| Jul 25, 2013 | DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone softw... | An anomaly was detected such that, under certain conditions, a summed dose created by Velocity re... | Class II | Velocity Medical Solutions, LLC |
| Jul 15, 2013 | StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... | Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... | Class II | Medtronic Navigation, Inc. |
| Jul 10, 2013 | Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M... | Software issue results in inaccurate 3D image may result in ablation in wrong location. | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 1, 2013 | Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performan... | The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jul 1, 2013 | CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used wit... | The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jul 1, 2013 | RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and T... | The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jun 26, 2013 | ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21... | Siemens issued a customer safety advisory notice and field safety corrective action for a potenti... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 21, 2013 | MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e... | Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue asso... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Jun 21, 2013 | Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2... | Notes associated with prescription are not printed to the prescription or to the patient chart. | Class II | Picis Inc. |
| Jun 20, 2013 | TDHistology/Cytology Classification name: Calculator/data processing modul... | A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... | Class III | Technidata S.A. |
| Jun 19, 2013 | Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Disp... | Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 12, 2013 | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibril... | The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to... | Class II | Physio Control, Inc. |
| Jun 7, 2013 | Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... | Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer... | Class II | Del Mar Reynolds Medical, Ltd. |
| Jun 4, 2013 | Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 1... | Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue wit... | Class I | Respironics California Inc |
| Jun 3, 2013 | AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Soft... | The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyz... | Class II | Beckman Coulter Inc. |
| May 24, 2013 | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalm... | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory fun... | Class II | Nidek Inc |
| May 20, 2013 | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - l... | There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample dil... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2013 | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data E... | During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-1... | Class II | Cincinnati Sub-Zero Products Inc |
| May 14, 2013 | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... | Class III | Optovue, Inc. |
| May 9, 2013 | GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... | GE Healthcare has recently become aware of a potential safety issue with respect to the automated... | Class II | GE Healthcare, LLC |
| May 7, 2013 | Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system | Siemens became aware of an unintended behavior when using the Luminos dRF with software version V... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2013 | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with sof... | Siemens has discovered through product monitoring a potential malfunction when using system opera... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Multiple studies were missing at a customer location that never made it to the archive before wat... | Class II | Merge Healthcare, Inc. |
| May 6, 2013 | ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ S... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 T... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device ... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 22, 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... | Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... | Class I | Brainlab AG |
| Apr 19, 2013 | Centricity Enterprise Archive is a software product for receiving, archiving ... | GE Healthcare has become aware of a potential data loss issue associated with empty path names re... | Class II | Ge Healthcare It |
| Apr 15, 2013 | Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, I... | Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core,... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 9, 2013 | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103... | Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the ... | Class II | Alpine Biomed Aps |
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.