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 |
|---|---|---|---|---|
| Nov 19, 2021 | SOMATOM Definition Edge -Computed tomography system Model 10590000 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Definition AS-Computed tomography system Model 8098027 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Edge Plus-Computed tomography system Model 1026700 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 18, 2021 | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automat... | (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for O... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 12, 2021 | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 12, 2021 | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging a... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 11, 2021 | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Ins... | Due to product label/labeling being altered from it's approved state. | Class II | Orchestrate Orthodontic Technologies, Inc. |
| Nov 11, 2021 | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer syn... | Class I | Medtronic Navigation, Inc. |
| Nov 3, 2021 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... | Class II | Haag-Streit USA Inc |
| Nov 3, 2021 | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... | Class II | Haag-Streit USA Inc |
| Oct 20, 2021 | Artis zee multi-purpose with software VD12-angiography systems developed for ... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q.zen floor with software VD12-angiography systems developed for single... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q ceiling with software VD12-angiography systems developed for single a... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis zee biplane with software VD12-angiography systems developed for single... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q.zen biplane with software VD12- angiography systems developed for sin... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis zee ceiling with software VD12-angiography systems developed for single... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis zee floor with software VD12-angiography systems developed for single a... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q biplane with software VD12-angiography systems developed for single a... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q floor with software VD12- angiography systems developed for single an... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q.zen ceiling with software VD12-angiography systems developed for sing... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2021 | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Numb... | An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in er... | Class II | InfuTronix LLC |
| Oct 14, 2021 | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 12, 2021 | Medtronic CareLink SmartSync Device Manager application software (D00U005) us... | The processing of collected episode data may fail due to a software error. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 12, 2021 | Artis icono floor with software VE20C-diagnostic imaging angiography system ... | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2021 | Artis icono biplane with software VE20C-diagnostic imaging angiography system... | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2021 | Artis pheno with software VE20C- diagnostic imaging angiography system Mode... | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 5, 2021 | Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10... | System operator manual states that the system should be rebooted once, every 7 days. In some case... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 4, 2021 | Cliquid MD version 3.4 software used in conjunction with Analyst MD software ... | The values of the Internal Standard (IS) concentrations are incorrectly derived when the user bui... | Class II | AB SCIEX |
| Sep 29, 2021 | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ... | Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... | Class II | Abbott Laboratories |
| Sep 29, 2021 | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/... | Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... | Class II | Abbott Laboratories |
| Sep 29, 2021 | Hemodialysis Delivery System, Software Version 2.x. | If the operator initiates therapy with a saved prescription profile and makes a change to the pr... | Class II | Baxter Healthcare Corporation |
| Sep 24, 2021 | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This ... | Class II | Philips Healthcare |
| Sep 24, 2021 | Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 i... | Software error, the software can produce an incorrect interpretation of the table rotation if the... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 24, 2021 | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.... | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) b... | Class II | Philips North America Llc |
| Sep 23, 2021 | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | Class II | Medtronic Neuromodulation |
| Sep 22, 2021 | da Vinci SP Surgical systems with the following Model Name/ Model Number / UD... | Issue was identified during internal engineering evaluation. Use of the system with the affected ... | Class II | Intuitive Surgical, Inc. |
| Sep 22, 2021 | ROSA One 3.1 Brain application The device is intended for the spatial posi... | The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le... | Class I | MEDTECH SAS |
| Sep 21, 2021 | EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 | Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unr... | Class II | Philips Ultrasound Inc |
| Sep 10, 2021 | Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ... | Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... | Class II | Draeger Medical, Inc. |
| Sep 10, 2021 | Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for t... | Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... | Class II | Draeger Medical, Inc. |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 31, 2021 | Medtronic Sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 30, 2021 | SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 30, 2021 | SOMATOM Drive with software syngo.CT VB20 Model #10431700 | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... | 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.