Browse Device Recalls
3,099 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,099 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 3,099 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 1, 2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... | Class II | Nidek Inc |
| Jun 28, 2016 | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with softw... | In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be un... | Class II | B-K Medical A/S |
| Jun 23, 2016 | Syngo.via, picture archiving and communications system software controlled. ... | Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2016 | Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... | Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 22, 2016 | Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical ... | Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in tes... | Class II | Olympus Scientific Solutions Americas |
| Jun 22, 2016 | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... | Risk associated with operating the device in skin temperature mode with temperature sensors attac... | Class II | Draeger Medical, Inc. |
| Jun 16, 2016 | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 14, 2016 | The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... | WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... | Class II | WalkMed Infusion, LLC |
| Jun 14, 2016 | The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... | WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... | Class II | WalkMed Infusion, LLC |
| Jun 6, 2016 | SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... | Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... | Class II | Siemens Medical Solutions USA, Inc |
| May 26, 2016 | ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197... | Eight (8) issues were identified which may affect the results generated by the system software ve... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 26, 2016 | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... | Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Mon... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| May 25, 2016 | BrightView X, model #882478; gamma camera designed for single or dual detecto... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Upgrade Model 882454 | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | iConnect Access software. The firm name on the label is Merge Healthcare, Ha... | Software displayed incorrect prior reports in the viewport area, only when more than one prior st... | Class II | Merge Healthcare, Inc. |
| May 18, 2016 | Proteus 235 and Proteus ONE proton therapy systems | Recall is being initiated to address on-site software installations not being performed consisten... | Class II | Ion Beam Applications S.A. |
| May 16, 2016 | enGen Laboratory Automation System, Product Code engen, Software Versions enG... | If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri... | Class III | Ortho-Clinical Diagnostics |
| May 12, 2016 | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Centr... | A patient weight can be populated incorrectly under certain conditions when using the RESTORE fea... | Class II | CareFusion 303, Inc. |
| May 10, 2016 | Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS softwa... | Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Load... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| May 9, 2016 | Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... | Software error in previous software versions in which two references for the same image may exist... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2016 | Ariol is an automated scanning microscope and image analysis system. It is in... | An issue during the manufacturing process caused systems to have an improperly activated Windows ... | Class III | Leica Biosystems Richmond Inc. |
| Apr 29, 2016 | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the... | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the b... | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, co... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuit... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 25, 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital networ... | Class II | Volcano Corporation |
| Apr 20, 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 15, 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge... | There are potential issues with results reporting for certain run-based tests. Under certain con... | Class II | Merge Healthcare, Inc. |
| Apr 15, 2016 | Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnost... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien 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.