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 23, 2023 | wDR 2.2 Mobile Digital Diagnostic X-Ray System | There is a software login in issue that may prevent the user from logging in. | Class II | SEDECAL SA |
| May 22, 2023 | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI... | Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen... | Class II | CareFusion 303, Inc. |
| May 19, 2023 | DigitalDiagnost C90, Model No. 712034 and 712035 | There is a software login in issue that may prevent the user from logging in. | Class II | Philips North America Llc |
| May 16, 2023 | Aptio Automation Storage and Retrieval Module (SRM) | A firmware error may lead to an incorrect association of test result(s) to a sample ID and theref... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 10, 2023 | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-S... | Class II | Fresenius Kabi USA, LLC |
| May 5, 2023 | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 5, 2023 | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 4, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc... | Class III | Datascope Corp. |
| May 2, 2023 | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring Syste... | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed ... | Class II | SenTec AG |
| Apr 25, 2023 | FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-011... | The firm has identified an increased risk of obtaining false positive Cryptosporidium results fro... | Class II | BioFire Diagnostics, LLC |
| Apr 19, 2023 | Patient Information Center iX, Product Code 866386, and Patient Information C... | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... | Class II | Philips North America |
| Apr 12, 2023 | Ultraview SL (UVSL) Command Module, Model 91496 | Command modules will display the following when parameter processing is suspended, depending on s... | Class II | Spacelabs Healthcare, Inc. |
| Apr 11, 2023 | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ... | Class I | Medtronic Navigation, Inc. |
| Apr 11, 2023 | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau... | Class I | Medtronic Navigation, Inc. |
| Apr 5, 2023 | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia... | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... | Class II | Draeger Medical Systems, Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... | Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls... | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... | Class II | Draeger Medical Systems, Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... | Due to an automated dispensing cabinet software issue, when a medication single order contains mo... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Illumina, Inc. |
| Apr 5, 2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS... | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Illumina, Inc. |
| Mar 27, 2023 | TDHisto/Cyto - A software product used for managing medical information in th... | In a specific use case, when printing labels for slides, some labels may display wrong information | Class II | Technidata S.A. |
| Mar 22, 2023 | BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 a... | Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A... | Class II | Becton Dickinson & Co. |
| Mar 21, 2023 | Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.... | Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 14, 2023 | HAMILTON-C6, REF: 160021 | Software error causes, safety ventilation, in which ventilation continues in the "safety ventilat... | Class II | Hamilton Medical AG |
| Mar 10, 2023 | Alinity h Interface Module (HSQ)-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 | PVT Interface Module (PVT)-Laboratory Automation system Brand names of the... | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... | Class II | Inpeco S.A. |
| Mar 10, 2023 | Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand... | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... | Class II | Inpeco S.A. |
| 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 |
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.