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 |
|---|---|---|---|---|
| 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 |
| Mar 1, 2017 | Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx | Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co... | Class II | Roche Diagnostics Corporation |
| Mar 1, 2017 | Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx | "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C... | Class II | Roche Diagnostics Corporation |
| Feb 27, 2017 | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim... | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... | Class II | LIEBEL-FLARSHEIM COMPANY LLC |
| Feb 27, 2017 | Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim ur... | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... | Class II | LIEBEL-FLARSHEIM COMPANY LLC |
| Feb 27, 2017 | MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... | Unapproved change made by the supplier. | Class II | Zimmer Biomet, Inc. |
| Feb 23, 2017 | Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... | Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 20, 2017 | Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... | Software updates | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2017 | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... | Firm has received reports of device operators failing to adhere to instructions for use pertainin... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2017 | ARTISTE" MV System | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | Mevatron M2/Primus Mid-Energy PRIMUS HI | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Expression ONCOR" Impression ONCOR" Impression plus | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Avant-garde | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2017 | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... | Multiple software issues, which may affect the operation and workflow of the system. Potential fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 1, 2017 | Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... | During treatment planning, the procedure was programmed with an unintended (wrong) correction. | Class II | Nidek Inc |
| Feb 1, 2017 | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... | The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... | Class II | Respironics California Inc |
| Jan 31, 2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... | Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... | Class II | Medtronic Inc. |
| Jan 26, 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... | SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... | Class II | Baxter Healthcare Corporation |
| Jan 23, 2017 | Merge LIS | A defect in the software resulted in medications that are not associated with the patient (i.e., ... | Class II | Merge Healthcare, Inc. |
| Jan 18, 2017 | Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation ... | An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software pro... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 14, 2017 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated B... | Indications for use are not cleared or approved for market in the U.S. | Class II | Med-Hot Thermal Imaging, Inc. |
| Jan 11, 2017 | Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... | Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... | Class II | Ortho Kinematics, Inc |
| Jan 11, 2017 | VIDAS 3 software v. 1.1.4 | During development of the VIDAS 3 software version 1.2, some anomalies have been identified and o... | Class II | BioMerieux SA |
| Jan 11, 2017 | Syngo.plaza, picture archiving and communications system. | Software update for improvements and to resolve several issues | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2017 | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product... | Software error | Class II | Siemens Medical Solutions USA, Inc |
| Jan 5, 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... | There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... | Class II | Haag-Streit USA Inc |
| Dec 30, 2016 | Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ... | Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,... | Class II | Hospira Inc., A Pfizer Company |
| Dec 23, 2016 | Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati... | Cross profile for Varian 60 degree wedge shows "horns." | Class II | Elekta, Inc. |
| Dec 22, 2016 | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database an... | A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV ... | Class II | AGFA Healthcare Corp. |
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.