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 |
|---|---|---|---|---|
| Nov 5, 2014 | EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | BrightView product code: 882478 BrightView X product code: 882480 BrightVie... | Software issues | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 31, 2014 | CyberKnife Robotic Radiosurgery System with the first generation IRIS Variabl... | Software upgrade to correct potential safety issue related to CyberKnife System that occurs when ... | Class II | Accuray Incorporated |
| Oct 30, 2014 | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images th... | Reduced mammographic image quality when attempting to print true size multi-format images | Class II | Carestream Health, Inc. |
| Oct 23, 2014 | Abbott m2000sp, an automated system for performing sample preparation for nuc... | Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw... | Class II | Abbott Molecular |
| Oct 23, 2014 | JResultNet drivers using ASTM coding language. Calculator/data processing mo... | Software issue resulting in the results of one patient potentially being associated with another. | Class II | Data Innovations, LLC |
| Oct 17, 2014 | Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid... | Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Oct 17, 2014 | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0... | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid... | Class II | INO Therapeutics (dba Ikaria) |
| Oct 3, 2014 | Philips Avalon Monitors with software revision J.30.58: Model Product F... | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... | Class II | Philips Medical Systems, Inc. |
| Oct 3, 2014 | Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo... | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... | Class II | Philips Medical Systems, Inc. |
| Oct 1, 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... | A software issue may lead to ventilator inoperative situations. | Class I | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 29, 2014 | CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-... | Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"... | Class II | Smiths Medical ASD, Inc. |
| Sep 25, 2014 | COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear ... | Error in the software. A deviation between reconstructed and planned dose distribution may not b... | Class II | Iba Dosimetry Gmbh |
| Sep 17, 2014 | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical... | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass... | Class II | Intuitive Surgical, Inc. |
| Sep 12, 2014 | nordicICE 2.3.14 Image processing software package used by trained profess... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Sep 8, 2014 | VITROS 5600 Integrated System, System Product Code 6802413. For use in the... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 5, 2014 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | The software issue described was corrected in the modification to the MXTTOUT controller paramete... | Class II | Zimmer Biomet, Inc. |
| Sep 1, 2014 | Fluid Management System P4000; for irrigation and fluid warming in laparosco... | To correct software bugs that could affect the ability to accurately measure fluid deficit. | Class II | Thermedx LLC |
| Aug 29, 2014 | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... | Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has d... | Class II | Dako North America Inc. |
| Aug 28, 2014 | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components ... | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studie... | Class II | Merge Healthcare, Inc. |
| Aug 27, 2014 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic mon... | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglo... | Class II | Mckesson Information Solutions LLC |
| Aug 27, 2014 | The Ysio Systems with software version VC10 The Ysio enables radiographic ... | Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 25, 2014 | EpiCenter Plus Microbiology Data Management System software version 6.20A, wh... | The information in the EpiCenter interface translation tables was not updated to match the Bruker... | Class II | Becton Dickinson & Co. |
| Aug 21, 2014 | TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In... | The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen ... | Class II | Maquet Medical Systems USA |
| Aug 21, 2014 | Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions... | When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView,... | Class II | Philips Medical Systems, Inc. |
| Aug 19, 2014 | Siemens CentraLink Data Management System, software version 14. The Cent... | Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Da... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2014 | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JR... | Potential issues with the ProVue driver have been identified which may cause data to be misassoci... | Class II | Data Innovations, LLC |
| Aug 13, 2014 | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ... | BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th... | Class III | Biofire Defense |
| Aug 12, 2014 | The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | The Siemens Symbia T series is intended for use by appropriately trained heal... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | The Siemens Symbia S series is intended for use by appropriately trained heal... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 7, 2014 | Philips IntelliSpace ECG Management System, with software option C61 needed ... | Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Q... | Class II | Philips Medical Systems, Inc. |
| Jul 31, 2014 | Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th... | It was discovered that a software defect may result in the scanner not terminating the CT scan a... | Class II | Philips Medical Systems, Inc. |
| Jul 31, 2014 | Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 45356044604... | Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 ... | Class II | Philips Electronics North America Corporation |
| Jul 28, 2014 | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... | Class II | Illumina Inc |
| Jul 27, 2014 | IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli... | The following software issues have been identified in the affected products. Problem 1: When reo... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 24, 2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image... | A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... | Class II | Philips Healthcare Informatics, Inc. |
| Jul 17, 2014 | Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ... | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2014 | Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other elect... | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... | Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (H... | Class II | TomoTherapy Incorporated |
| Jul 16, 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... | Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ ... | Class II | TomoTherapy Incorporated |
| Jul 15, 2014 | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vit... | Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrec... | Class II | Ab Sciex |
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.