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 |
|---|---|---|---|---|
| Dec 22, 2016 | Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reportin... | Power outages causes reporting software to shutdown. | Class II | Tosoh Smd Inc |
| Dec 21, 2016 | AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | Agfa Healthcare NX 3.0.8950 Imaging Processing Software | A customer reported that when using an NX workstation with software version NX 3.0.8950 software ... | Class II | AGFA Healthcare Corp. |
| Dec 20, 2016 | Accu-Chek Connect Diabetes Management App | iOS and Android: Under certain conditions the affected app versions may disregard historical bolu... | Class II | Roche Diabetes Care, Inc. |
| Dec 16, 2016 | IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec... | Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 16, 2016 | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version N... | A software error caused the window/level to become the same in one series regardless if the image... | Class II | DICOM GRID INC |
| Dec 13, 2016 | Proteus 235, Proton Therapy System Product Usage: The Proton Therapy Syst... | Software issue | Class II | Ion Beam Applications S.A. |
| Dec 8, 2016 | Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis syst... | Siemens initiated a corrective action to address two possible, mutually independent causes of a s... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 8, 2016 | Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis sys... | Siemens initiated a corrective action to address two possible, mutually independent causes of a s... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 2, 2016 | Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... | Class II | Polymer Technology Systems |
| Dec 2, 2016 | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... | Class II | Polymer Technology Systems |
| Dec 2, 2016 | A1CNow+ Systems (professional use product), Software Version Revision D, REF ... | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... | Class II | Polymer Technology Systems |
| Dec 2, 2016 | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... | Class II | Polymer Technology Systems |
| Dec 2, 2016 | A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, ... | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... | Class II | Polymer Technology Systems |
| Dec 1, 2016 | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... | Issue may cause eReports to consume an excessive amount of disk space causing the software to sto... | Class II | PerkinElmer Health Sciences, Inc. |
| Nov 29, 2016 | CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The C... | There is a remote possibility CentraLink may download an order to the ADVIA Automation System wit... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 23, 2016 | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... | Design error when displaying additional information in the patient view window; error may result ... | Class II | Radiometer America Inc |
| Nov 22, 2016 | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/... | Accuray has become aware of a potential safety issue involving unexpected treatment robot motion ... | Class II | Accuray Incorporated |
| Nov 21, 2016 | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738... | Software error; Carestream Health Inc, received a complaint stating that when a user accidentally... | Class II | Carestream Health Inc |
| Nov 15, 2016 | SOMATOM Definition Flash System, x-ray, tomography, computed Intended to pro... | 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 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. |
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.