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 |
|---|---|---|---|---|
| Dec 21, 2022 | Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system f... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 19, 2022 | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected w... | A software bug eliminated the initial ECG activation and review of the ECG under a physician. How... | Class II | Withings |
| Dec 12, 2022 | BD Pyxis MedBank System - Product Label/labeling pending | Due to customer complaints related to the MedBank software which may indicate that a different me... | Class II | CareFusion 303, Inc. |
| Dec 12, 2022 | cobas infinity central lab, Material Number 07154003001 | A complaint investigation revealed that an incorrect behavior relating to the rejection of orders... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 5, 2022 | Agfa HealthCare Enterprise Imaging XERO Viewer | There is a software defect that can cause issues with images. | Class II | Agfa Healthcare NV |
| Dec 5, 2022 | Oncentra Brachy radiation therapy planning system software. | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Mode... | Class II | Elekta, Inc. |
| Dec 5, 2022 | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE... | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can ... | Class I | Cardiac Assist, Inc |
| Dec 5, 2022 | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 ... | 3D orthodontic planning software has a defect that leads to an issue where incorrect number of al... | Class II | Align Technology Inc |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Nov 18, 2022 | The 4Kscore Test is an in vitro serum or plasma test that combines the result... | SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results | Class II | BioReference Health, LLC |
| Nov 18, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... | Class II | Mobius Imaging, LLC |
| Nov 16, 2022 | Programmable Diagnostic Computer | The firm will be performing a software update to address a software error which affects the liste... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 9, 2022 | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3... | When selecting the site fraction group for treatment, the User may select the wrong site for trea... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2022 | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | Abbott has identified potential performance issues for the Alinity m System software version 1.6.... | Class II | Abbott Molecular, Inc. |
| Oct 10, 2022 | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or ... | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record sy... | Class II | Smiths Medical ASD Inc. |
| Sep 30, 2022 | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 30, 2022 | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 28, 2022 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the so... | Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, i... | Class II | X-NAV Technologies, LLC |
| Sep 20, 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens has become aware of three potential software issues with ARTIS pheno systems with softwar... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 16, 2022 | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop)... | Class II | Fresenius Kabi USA, LLC |
| Sep 8, 2022 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | The display screen may become frozen and unresponsive to user input, triggering an alarm that is ... | Class I | Fresenius Kabi USA, LLC |
| Aug 31, 2022 | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 | Software calibration error with product equip with a Dose Area Product (DAP) meter. This results... | Class II | Micro-X Ltd. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. ... | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Jul 27, 2022 | 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute a... | (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, ha... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jul 21, 2022 | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen ... | Class I | Cardiac Assist, Inc |
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... | Class III | NuVasive Inc |
| Jul 14, 2022 | cobas e801 Immunoassay Analyzer | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2022 | Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... | Class II | Aesculap Implant Systems LLC |
| Jul 13, 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... | There are 7 reported software anomalies that may affect use of the device. | Class II | bioMerieux, Inc. |
| Jul 12, 2022 | Surpria: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | Surpria 64: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 8, 2022 | Pentacam HR REF 70900. Used to image the anterior segment of the eye. | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 8, 2022 | Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 8, 2022 | Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 7, 2022 | The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 5, 2022 | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... | Class II | Zap Surgical Systems |
| Jun 23, 2022 | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) ... | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible ... | Class II | Mallinckrodt, LLC. |
| Jun 23, 2022 | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and an... | A race condition between the storage system and services database has the potential to revert edi... | Class II | DICOM Grid, Inc. d/b/a Ambra Health |
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.