Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 4, 2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro deter... | Abnormal premature termination of the software could affect the use of the analyser when running ... | Class II | Randox Laboratories |
| Apr 30, 2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... | Five warning statements are missing from the instructions for use. | Class II | Philips Electronics North America Corporation |
| Apr 30, 2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... | Five warning statements are missing from the instructions for use. | Class II | Philips Electronics North America Corporation |
| Apr 30, 2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... | Five warning statements are missing from the instructions for use. | Class II | Philips Electronics North America Corporation |
| Apr 30, 2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... | Five warning statements are missing from the instructions for use. | Class II | Philips Electronics North America Corporation |
| Apr 23, 2018 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4... | The fuel gauge, the component that reads and reports the battery parameters to the pump, could pr... | Class II | Tandem Diabetes Care Inc |
| Apr 20, 2018 | SOMATOM go.Now, Material Number 11061618 There is a potential for a softw... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2018 | SOMATOM Go.Up, Material Number 11061628 There is a potential for a softwar... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 16, 2018 | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 13, 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Apr 3, 2018 | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is ... | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical s... | Class II | Roche Diagnostics Corporation |
| Mar 29, 2018 | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iC... | The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufac... | Class II | Beckman Coulter Inc. |
| Mar 28, 2018 | RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 ... | The dose calculation accuracy may in some situations be less than expected. The user must be awar... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2018 | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS2040... | Software anomaly resulting in the loss of patient settings and stored patient data. | Class II | Draegar Medical Systems, Inc. |
| Mar 2, 2018 | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 70... | Beckman Coulter has determined that there is a potential for under-reporting casts. This can occu... | Class II | Beckman Coulter Inc. |
| Mar 2, 2018 | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... | Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... | Class II | Beckman Coulter Inc. |
| Feb 27, 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may res... | Class II | Radiometer Medical ApS |
| Feb 22, 2018 | Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 333713869... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 333715469... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 331352269... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| 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 |
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.