Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 10, 2023 | Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names... | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... | Class II | Inpeco S.A. |
| Mar 10, 2023 | Storage and Retrieval Module (SRM)-Laboratory Automation system Brand name... | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... | Class II | Inpeco S.A. |
| Mar 8, 2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The... | Due to potential software issue that may result in patient mix-up information. | Class II | Radiometer Medical ApS |
| Mar 6, 2023 | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 6, 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 1, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE... | Due to a software issue where the process of patient scanning, the scatter correction may occasio... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Feb 27, 2023 | RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device fo... | There is the potential for the program software to malfunction which will not allow it to move fo... | Class II | Appliedvr |
| Feb 17, 2023 | Raystation treatment planning system for radiation therapy, Model Numbers 9.0... | It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle wil... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 14, 2023 | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therap... | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a stand... | Class II | Brainlab AG |
| Feb 10, 2023 | Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software... | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may de... | Class II | Sensus Healthcare, Inc. |
| Feb 2, 2023 | LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Sof... | Under specific circumstances, the U.S. product registration system did not send up enablement req... | Class II | Boston Scientific Corporation |
| Jan 25, 2023 | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L ... | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... | Class II | Stryker Corporation |
| Jan 25, 2023 | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L ... | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... | Class II | Stryker Corporation |
| Jan 25, 2023 | Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the ... | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... | Class II | Stryker Corporation |
| Jan 24, 2023 | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a ne... | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of i... | Class II | Outset Medical, Inc. |
| Jan 24, 2023 | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network car... | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless con... | Class II | CareFusion 303, Inc. |
| Dec 23, 2022 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts ... | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Dec 22, 2022 | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 22, 2022 | Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, ... | Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... | Class I | Getinge Usa Sales Inc |
| Dec 22, 2022 | Getinge Flow-c Anesthesia System, Part No. 6887700 | Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... | Class I | Getinge Usa Sales Inc |
| Dec 22, 2022 | Getinge Flow-e Anesthesia System, Part No. 6887900 | Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... | Class I | Getinge Usa Sales Inc |
| Dec 21, 2022 | Luminos dRF with software VD10- A diagnostic imaging system for radiographic... | 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 with software VC10 - A diagnostic imaging system for radiograp... | 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 | 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 |
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.