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 |
|---|---|---|---|---|
| Nov 15, 2016 | SOMATOM Definition AS System, x-ray, tomography, computed Intended to produc... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 15, 2016 | SOMATOM Definition Edge System, x-ray, tomography, computed Intended to prod... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 14, 2016 | IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cr... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 14, 2016 | Philips Spectral CT Applications supports viewing and analysis of images at e... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728232 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 128 728323 | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cr... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce ... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728231 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 9, 2016 | RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System... | Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation ... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 3, 2016 | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | Software malfunction that results in incorrect generation or display of error codes. | Class II | Olympus Corporation of the Americas |
| Nov 2, 2016 | SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM ... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2016 | SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATO... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2016 | SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMAT... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 31, 2016 | MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: coba... | Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and ca... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 28, 2016 | 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usag... | IBA is initiating this recall to address an issue identified with AdaPTinsight software and to re... | Class II | Ion Beam Applications S.A. |
| Oct 20, 2016 | Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a... | A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio... | Class II | Merge Healthcare, Inc. |
| Oct 20, 2016 | SOMATOM Force, System x-ray, tomography, computed | Siemens is providing software update version VA50A_SP3 to address the software bugs that were i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2016 | MEVION S250 Product Usage: Proton Radiation Therapy System | Software defect:2D projection of contours in Verity. The defect causes structures to appear off f... | Class II | Mevion Medical Systems, Inc. |
| Oct 11, 2016 | Radiation Therapy Treatment Planning System Product Usage: RayStation is... | An error may occur with the display of dose computed on images other than the planning CT (auxili... | Class II | RAYSEARCH LABORATORIES AB |
| Oct 6, 2016 | Softbank software Product Usage: Decision support software for transfusio... | Software error. Potential for incorrect results | Class II | Soft Computer Consultants, Inc. |
| Oct 6, 2016 | SCC Soft Computer Softbank II software Product Usage: Supports single and... | Software error. Potential for incorrect results | Class II | Soft Computer Consultants, Inc. |
| Oct 5, 2016 | da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;... | Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can resu... | Class II | Intuitive Surgical, Inc. |
| Oct 3, 2016 | Medtronic SynchroMed II Implantable Drug Infusion System. This system includ... | Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th... | Class I | Medtronic Neuromodulation |
| Oct 3, 2016 | TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical devic... | The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsig... | Class II | Medimaps Group |
| Sep 27, 2016 | Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for cl... | cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 15, 2016 | Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx,... | Image data for a patients image may not be correct | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Sep 14, 2016 | Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on ... | Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect... | Class II | Roche Diabetes Care, Inc. |
| Sep 7, 2016 | enGen Laboratory Automation System (Product Code ENGEN) configured with Therm... | Ortho confirmed that it is possible for the mis-association of sample identification and assay re... | Class II | Ortho-Clinical Diagnostics |
| Sep 6, 2016 | Syngo.plaza VB10A, Picture Archiving and Communication System | Software upgrade to eliminate several issues | Class II | Siemens Medical Solutions USA, Inc |
| Sep 6, 2016 | Syngo.plaza, Picture Archiving and Communication System | Software upgrade to eliminate several issues | Class II | Siemens Medical Solutions USA, Inc |
| Sep 1, 2016 | RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radi... | RaySearch became aware of the problem as it was discovered in cooperation with a customer experim... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 31, 2016 | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P0... | The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... | Class II | Neusoft Medical Systems Co., Ltd. |
| Aug 15, 2016 | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5... | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Syst... | Class II | Biosense Webster, Inc. |
| Aug 12, 2016 | Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. ... | Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug... | Class II | Ortho Kinematics, Inc |
| Aug 12, 2016 | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation... | Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, an... | Class II | Novarad Corporation |
| Aug 8, 2016 | Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syr... | A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to ... | Class II | CareFusion 303, Inc. |
| Aug 8, 2016 | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: Th... | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis ... | Class II | Nidek Inc |
| Aug 5, 2016 | Syngo.via picture archiving and communication system Syngo via is a softwa... | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 5, 2016 | Syngo.x picture archiving and communication system Syngo.x is a software s... | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 5, 2016 | CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the... | Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ... | Class II | Medtronic Inc. |
| Aug 4, 2016 | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultras... | Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System beca... | Class II | Toshiba American Medical Systems Inc |
| Jul 28, 2016 | Hospira MedNet Medication Management Suite software, version 6.1, List Number... | Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result... | Class II | Hospira Inc., A Pfizer Company |
| Jul 27, 2016 | CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's v... | A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time dat... | Class II | INNOKAS MEDICAL OY |
| Jul 26, 2016 | ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS brande... | Software patch installation to address several safety issues. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 26, 2016 | PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerat... | Software patch installation to address several safety issues. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 26, 2016 | Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a sof... | Software patch installation to address several safety issues. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 25, 2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, 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.