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 |
|---|---|---|---|---|
| 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. |
| Jul 25, 2016 | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 20, 2016 | Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-r... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | ROSA Brain 3.0.0 Usage: The device is intended for the spatial positionin... | Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. | Class II | Zimmer Biomet, Inc. |
| Jul 20, 2016 | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA... | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System So... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 20, 2016 | Brilliance BigBore Radiology CT Model number 728244 Product Usage: Comput... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Compu... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomog... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 19, 2016 | Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 ... | Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software ver... | Class II | Thermo Finnigan LLC |
| Jul 18, 2016 | MACH Cranial Treon. The software application is sent in CD format with an IFU... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | MACH AxiEM Cranial Treon. The software application is sent in CD format with ... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Synergy Spine. The software application is sent in CD format with an IFU, wra... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Fusion ENT Application. The software application is sent in CD format with an... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Synergy Cranial S7. The software application is sent in CD format with an IFU... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | FrameLink. The software application is sent in CD format with an IFU, wrapped... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | S7 MACH FrameLink. The software application is sent in CD format with an IFU,... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 15, 2016 | RSD 800A Aliquoting System calculator/data processing module, for clinical u... | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 15, 2016 | cobas p 612 Pre-Analytical Instrument calculator/data processing module, for... | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2016 | Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30... | It was reported by a customer that RadSuite images are not appearing as readable images. Thi... | Class II | Merge Healthcare, Inc. |
| Jul 13, 2016 | SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 co... | Due to an internal communication error between the firmware and the software of the components, t... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, c... | Due to an internal communication error between the firmware and the software of the components, t... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, co... | Due to an internal communication error between the firmware and the software of the components, t... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 12, 2016 | Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: Th... | Software malfunction; The action being taken due to the device becoming inoperable due to softwa... | Class III | ELITech Group B.V. |
| Jul 8, 2016 | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE... | A software issue related to the generic volume measurement functionality could result in the volu... | Class II | Carestream Health Inc |
| Jul 7, 2016 | Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Mo... | Due to an error in the 19 Live Display, image reproduction may fail in the examination room and ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 5, 2016 | Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... | Class III | Siemens Healthcare Diagnostics 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.