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 |
|---|---|---|---|---|
| Aug 30, 2021 | SOMATOM Confidence with software syngo.CT VB20 Model #10590100 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 30, 2021 | SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 30, 2021 | SOMATOM Force with software syngo.CT VB20 Model #10742326 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 30, 2021 | SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 30, 2021 | SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 27, 2021 | Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft versi... | When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or Ver... | Class II | PTW NORTH AMERICA CORPORATION |
| Aug 18, 2021 | Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP... | Software versions may result in sporadic problems causing scanning workflow interruptions and un... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 16, 2021 | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclu... | When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... | Class II | Biodex Medical Systems, Inc. |
| Aug 16, 2021 | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusiv... | When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... | Class II | Biodex Medical Systems, Inc. |
| Aug 12, 2021 | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image proce... | A software anomaly exists in the Centricity Universal Viewer study management feature in which st... | Class II | GE Healthcare, LLC |
| Aug 10, 2021 | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are inten... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 10, 2021 | TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 10, 2021 | TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 10, 2021 | TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 10, 2021 | TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are inte... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 10, 2021 | TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 10, 2021 | TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... | Class II | DePuy Orthopaedics, Inc. |
| Aug 6, 2021 | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2... | Due to a software defect that can intermittently cause the system to lock-up which exiting Review... | Class II | Philips Ultrasound Inc |
| Aug 6, 2021 | Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5... | Due to a software defect that can intermittently cause the system to lock-up which exiting Review... | Class II | Philips Ultrasound Inc |
| Jul 26, 2021 | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan i... | Class II | Elekta Inc |
| Jul 26, 2021 | Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, ... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Alinity ci-series System Control Module clinical chemistry and immunoassay an... | Due to potential performance issues with software version 3.2.3 and earlier. Performance issues ... | Class II | Abbott Laboratories |
| Jul 26, 2021 | Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy Evo Universal, Product number DS2000X11B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 23, 2021 | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x... | Class II | Merge Healthcare, Inc. |
| Jul 20, 2021 | Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12... | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 15, 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017... | There is a potential that the data management system may add additional cells to the patient requ... | Class II | Beckman Coulter Inc. |
| Jul 12, 2021 | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vit... | A design defect (hardware and software) allows liquid waste pressure to build up and potentially ... | Class II | Abbott Laboratories, Inc |
| Jul 7, 2021 | Dose IQ Safety Software used with Spectrum IQ Infusion Pump | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose ... | Class I | Baxter Healthcare Corporation |
| Jun 30, 2021 | Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Ar... | Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 24, 2021 | cobas infinity central lab running software version 3.01.03 through 3.02.08, ... | Under specific circumstances created by the user, the cobas e flow test results could be replaced... | Class II | Roche Diagnostics Operations, Inc. |
| Jun 23, 2021 | Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10... | Software anomalies that may lead to the generation of erroneous results. | Class II | Beckman Coulter, Inc. |
| Jun 22, 2021 | MYLA software. Used to manage microbiology test workflow from the reception ... | Software anomaly - Under certain conditions, unwanted alterations to results could be applied whe... | Class II | BioMerieux SA |
| Jun 18, 2021 | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 18, 2021 | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 18, 2021 | Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system con... | Class II | WOM World of Medicine AG |
| Jun 14, 2021 | Revolution EVO, Optima CT660, Optima CT680 CT Systems. | Improperly loaded software options may result in additional X -ray radiation exposure to the pati... | Class II | GE Healthcare, LLC |
| Jun 8, 2021 | Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-r... | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iC... | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728332 IQon Spectral CT-Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728333 Spectral CT 7500 -Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 7, 2021 | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as ... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 7, 2021 | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, a... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 4, 2021 | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 357000... | System errors were noted following changes the customers implemented to the configuration of thei... | Class I | Baxter Healthcare Corporation |
| Jun 4, 2021 | Simpleware ScanIP medical software. For transfer of imaging information from... | A issue (bug) has been identified with the interface and image software which could result in an... | Class II | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
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.