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 |
|---|---|---|---|---|
| Feb 21, 2018 | True 3D Viewer, Model: EP-00003 | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images in... | Class II | Echopixel, Inc. |
| Feb 21, 2018 | Brilliance 64 with 4.1.7 XX026 software version model number 728231 Produc... | Surview scan with tube current lower than 30 mA is unable to be initialized. | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 20, 2018 | Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communicati... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2018 | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syn... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an int... | Following a period of inactivity, the mass storage device may cause the acquisition console to be... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 15, 2018 | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energ... | Lasers/Catheters did not calibrate during set-up prior to use. | Class II | Ra Medical Systems Inc |
| Feb 14, 2018 | ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product U... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Prod... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 019400... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 7, 2018 | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for us... | Update XL¿ device software to version A.03. This includes enhancements to the Operational Check... | Class III | Philips Electronics North America Corporation |
| Feb 1, 2018 | SOMATOM Scope ( Model 10967666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 16 (10165977) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Spirit(Model 10045692 ) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Scope Power (Model 10967888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective (Model 10495568) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective 16 (Model 10891666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 6 (Model 10165888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Jan 30, 2018 | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Size... | The firm received complaints regarding the incompatibility and dimensional interference between ... | Class II | Orthofix Srl |
| Jan 29, 2018 | Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter i... | Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... | Class II | Philips Electronics North America Corporation |
| Jan 29, 2018 | Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter i... | Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... | Class II | Philips Electronics North America Corporation |
| Jan 26, 2018 | Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build... | Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment v... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 26, 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray di... | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values ar... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 26, 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... | Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... | Class I | bioMerieux, Inc. |
| Jan 25, 2018 | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS... | Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inabili... | Class II | Medtronic Navigation, Inc.-Littleton |
| Jan 24, 2018 | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usa... | The recalling firm identified a software issue related to the Patient Line Check (PLC) which may ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 24, 2018 | DynaCad software consist of an MR Analysis Server software and the viewer wor... | Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not... | Class II | Invivo Corporation |
| Jan 23, 2018 | bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system c... | Missing desiccant. | Class II | Biomerieux Inc |
| Jan 17, 2018 | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version... | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Ce... | Class II | Spacelabs Healthcare Inc |
| Jan 12, 2018 | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 12, 2018 | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 11, 2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... | Class II | GE Medical Systems Information Technologies, Inc. |
| Jan 11, 2018 | IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Comput... | 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues inc... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 10, 2018 | Syngo.via software is intended to be used for viewing, manipulation, communic... | When the archiving configuration is changed, data received/created after the upgrade may be flagg... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2018 | Syngo.via. Medical Device Software. Picture archiving and communications sys... | A software functionality in the report sections Findings Information and Summary of Measured F... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 3, 2018 | Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244... | Software issues including: Software errors that may result in Extended Field of View check messa... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 3, 2018 | Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 ... | Software issues including: Software errors that may result in Extended Field of View check messa... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 3, 2018 | Intellivue iX Information Center Software - All PIIC iX Surveillance stations... | Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable ... | Class II | Philips Electronics North America Corporation |
| Dec 14, 2017 | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodial... | When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 13, 2017 | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401... | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted ... | Class II | Smith & Nephew, Inc. |
| Dec 11, 2017 | Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This d... | A software issue causes PET reconstructions to fail intermittently. It was determined that recons... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 8, 2017 | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Acc... | Due to a system controller software anomaly, the patient positioning deviation correction may not... | Class II | Hitachi Ltd., Medical System Operations Group |
| Dec 8, 2017 | CARESCAPE R860 ventilators with software version 10SP05 Product Usage: Th... | Potential for the display processor to experience an unexpected failure. | Class II | Datex-Ohmeda, Inc. |
| Dec 8, 2017 | Widefield OCT software feature for the Spectralis HRA+OCT and variants | FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefiel... | Class II | Heidelberg Engineering |
| Dec 6, 2017 | Health Harmony Mobile application software Product Usage: Care Innovatio... | It was discovered that in certain situations, including partial sessions and when taking adhoc me... | Class II | Intel-GE Care Innovations LLC |
| Dec 4, 2017 | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following pr... | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, a... | Class II | Cellavision AB |
| Dec 4, 2017 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... | Class II | Beckman Coulter Inc. |
| Dec 2, 2017 | Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software versi... | Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusio... | Class II | Fresenius Vial Sa |
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.