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 |
|---|---|---|---|---|
| Feb 25, 2022 | Artis icono biplane- in combination with a Siemens Healthineers table or Tru... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis icono floor in combination with a Siemens Healthineers table or Trumpf... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 22, 2022 | Philips Hemodynamic Application, Model Number 722463, Software Version Number... | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode ... | Class II | Philips North America Llc |
| Feb 14, 2022 | Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ve... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
| Feb 14, 2022 | Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the vent... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
| Feb 11, 2022 | RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayS... | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when usin... | Class II | RaySearch America Inc |
| Feb 3, 2022 | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... | Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash b... | Class II | Abbott Laboratories, Inc |
| Feb 2, 2022 | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029,... | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the ... | Class II | Philips North America Llc |
| Feb 2, 2022 | Philips StentBoost Live R2.0 application, when used with the Philips Azurion... | Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition doe... | Class II | Philips Healthcare |
| Jan 31, 2022 | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic s... | Siemens Healthineers has identified a software error in previous software version VB10 for the Ys... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 28, 2022 | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI:... | Distribution of Defibrillators that are not approved or cleared for distribution US Market. | Class II | Remote Diagnostic Technologies Ltd. |
| Jan 20, 2022 | The Sight OLO device is a computer vision based platform for blood analysis. ... | In instances where custom reference ranges were configured on the device post installation, a po... | Class II | SIGHT DIAGNOSTICS LTD |
| Jan 19, 2022 | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software versi... | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedura... | Class II | Volcano Corporation |
| Jan 14, 2022 | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general l... | A software defect in the camera control unit (CCU) will cause the image on the monitor to flip up... | Class II | Stryker Corporation |
| Jan 11, 2022 | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/... | Retinal analysis system software has some features, based on artificial intelligence, that potent... | Class II | Diagnos Inc |
| Jan 3, 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version ... | eCareManager (eCM) Sentry Score software not approved for use | Class II | Philips North America Llc |
| Dec 30, 2021 | RayStation/RayPlan- designed for treatment planning and analysis of radiation... | If a new primary image set is selected while the cine loop is running, the primary image set will... | Class II | RAYSEARCH LABORATORIES AB |
| Dec 20, 2021 | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita... | Risk of misidentification or delayed results with the absence of identification due to thermoform... | Class II | Biomerieux Inc |
| Dec 15, 2021 | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... | As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei... | Class II | Medtronic Xomed, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ... | Class II | Abbott Molecular, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software issue associated with the ability to properly complete a Field Service Engine... | Class II | Abbott Molecular, Inc. |
| Dec 3, 2021 | ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing a... | lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incor... | Class II | Konica Minolta Healthcare Americas, Inc. |
| Dec 2, 2021 | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neur... | Tile kits that allow one to install and situate a video camera within a patient environment are n... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Nov 29, 2021 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) ... | Class II | Ion Beam Applications S.A. |
| Nov 23, 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, mat... | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | 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 | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended f... | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mount... | Class II | Philips North America Llc |
| 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 |
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.