Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 27, 2017 | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory ... | A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with t... | Class II | Hologic, Inc |
| Jun 26, 2017 | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D24588... | The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the speci... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jun 20, 2017 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Vers... | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal a... | Class II | Beckman Coulter Inc. |
| Jun 19, 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profil... | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the... | Class II | Nova Biomedical Corporation |
| Jun 19, 2017 | iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni... | Incorrect PEC values. | Class II | Elekta, Inc. |
| Jun 14, 2017 | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used ... | Reports of the device failure involving delivering continuous pressure to the calf garment and no... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Jun 14, 2017 | mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Ma... | Potential failure in the balloon bond in the inner catheter stem, leading to the separation of th... | Class II | Medspira, Llc |
| Jun 13, 2017 | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo... | When the user has not set up any user preference on the sorting order to render the study images ... | Class II | Merge Healthcare, Inc. |
| Jun 8, 2017 | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN ... | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... | Class II | Roche Diabetes Care, Inc. |
| Jun 8, 2017 | Accu-Chek Connect diabetes management software app, Catalog number 0756246200... | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... | Class II | Roche Diabetes Care, Inc. |
| Jun 7, 2017 | Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: C... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usag... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Co... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to ... | An intermittent electrical problem that could lead to a loss of system power due to a loose screw... | Class II | Mako Surgical Corporation |
| Jun 7, 2017 | Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Produ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 31, 2017 | SoftLab Software Laboratory information system to be used in a medical res... | Display of lab results based on incorrect LOINC code/test descriptions for tests that were perfor... | Class II | Soft Computer Consultants, Inc. |
| May 24, 2017 | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... | Class II | Merge Healthcare, Inc. |
| May 24, 2017 | Merge OrthoPACS software. | A migrated study that has annotations will display the annotations, but when a prior study is loa... | Class II | Merge Healthcare, Inc. |
| May 22, 2017 | Syngo.plaza, Picture Archiving and Communications System(PACS), Model 1086317... | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. ... | Class II | Siemens Medical Solutions USA, Inc |
| May 19, 2017 | Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Mul... | Software defect | Class II | Neusoft Medical Systems Co., Ltd. |
| May 19, 2017 | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: Neu... | Software defect | Class II | Neusoft Medical Systems Co., Ltd. |
| May 16, 2017 | Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 109... | Software error. In Sensis Vibe systems with software version VD10B, a software error can result ... | Class II | Siemens Medical Solutions USA, Inc |
| May 10, 2017 | Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. | Software issue related to the StealthStation S7 system and the Synergy Spine application Version ... | Class II | Medtronic Navigation, Inc. |
| May 8, 2017 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk... | Class II | Merge Healthcare, Inc. |
| May 8, 2017 | Merge PACS software. Merge PACS (Picture Archiving Communication System) is... | When cut lines are shown on an image, the lines may go from being vertical and then shift to hori... | Class II | Merge Healthcare, Inc. |
| Apr 26, 2017 | enGen Track System with TCAutomation Software Version 4.2 | A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results d... | Class II | Ortho-Clinical Diagnostics |
| Apr 13, 2017 | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an elec... | Software bug which allows parameters to be changed unintentionally during use. | Class II | CardioTek BV |
| Apr 10, 2017 | RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... | Potential Patient Demographic Error with Blank Patient ID Field | Class II | Siemens Healthcare Diagnostics Inc |
| Apr 3, 2017 | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 ... | Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS S... | Class II | Beckman Coulter Inc. |
| Mar 31, 2017 | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and ... | Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da... | Class II | Intuitive Surgical, Inc. |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... | When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 28, 2017 | Artis zee, Angiographic x-ray system | Software error - As a result of a software fault in Artis zee systems with software version VD11 ... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 21, 2017 | Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... | Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and l... | Class II | Roche Diagnostics Corporation |
| Mar 14, 2017 | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS Sys... | Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... | Class II | Nexstim PLC |
| Mar 14, 2017 | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigat... | Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... | Class II | Nexstim PLC |
| Mar 13, 2017 | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1,... | Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Conce... | Class II | Accelerate Diagnostics Inc |
| Mar 8, 2017 | enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software ... | Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, s... | Class II | Ortho-Clinical Diagnostics |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Mar 6, 2017 | Syngo.via, Picture archiving and communication system Syngo via is a softwar... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 6, 2017 | Syngo.x, Picture archiving and communication system Syngo via is a software ... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2017 | eCare Coordinator Product Usage: is software intended for use in data ag... | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation,... | Class II | Philips Visicu |
| Mar 2, 2017 | Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA so... | Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VM... | Class II | Ortho Kinematics, 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.