Browse Device Recalls

49 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 49 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 49 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 19, 2025	Alphenix INFX-8000C, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Alphenix INFX-8000V, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Alphenix INFX-8000H, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	VANTAGE TITAN 3T Model MRT-3010/MEXL-3010	There is a potential for formation of ice occurring in the venting system of the superconducting ...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Alphenix INFX-8000F, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	VANTAGE GALAN 3T Model MRT-3020/MEXL-3020	There is a potential for formation of ice occurring in the venting system of the superconducting ...	Class II	Canon Medical System, USA, INC.
Oct 16, 2025	VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.	Affected system contains components that do not meet the required distance between electrodes for...	Class II	Canon Medical System, USA, INC.
Sep 2, 2025	This device is a digital radiography/fluoroscopy system used in a diagnostic ...	It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the c...	Class II	Canon Medical System, USA, INC.
Sep 17, 2024	Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a ...	When PET-CT system is executing reconstruction, if PET acquisition for another patient is perform...	Class II	Canon Medical System, USA, INC.
May 10, 2024	MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-...	The terminal block used to secure the power supply cable for the gradient coil of the MRI system ...	Class II	Canon Medical System, USA, INC.
Jan 29, 2024	MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550	For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val...	Class II	Canon Medical System, USA, INC.
Jan 29, 2024	Vantage Titan, Model: MRT-1504	For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val...	Class II	Canon Medical System, USA, INC.
Jan 29, 2024	MRI system: Vantage Elan, Model: MRT-2020	For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val...	Class II	Canon Medical System, USA, INC.
Nov 15, 2023	The device is an X-ray system that is capable of radiographic and fluoroscopi...	VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image...	Class II	Canon Medical System, USA, INC.
Nov 15, 2023	The INFX-8000F is designed to take advantage of the latest technological inno...	VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image...	Class II	Canon Medical System, USA, INC.
Jun 22, 2023	INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C...	The C-arm, used to set the position and angle of the x-ray exposure field, may not function due t...	Class II	Canon Medical System, USA, INC.
Sep 29, 2022	Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI...	After completion, ultrasound system's Stress Echo may not terminate if user does not manually ter...	Class II	Canon Medical System, USA, INC.
May 3, 2022	System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model ...	CT operation may be restricted by an interlock which is a result of an system error and the CT sy...	Class II	Canon Medical System, USA, INC.
Jan 31, 2022	INFX-8000V. For radiographic and fluoroscopic studies and intervention.	The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.	Class II	Canon Medical System, USA, INC.
Dec 20, 2021	Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, ...	Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible ...	Class II	Canon Medical System, USA, INC.
May 21, 2021	Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic im...	The MRI system contains a component that does not meet the appropriate flame retardancy-rating w...	Class II	Canon Medical System, USA, INC.
May 21, 2021	Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Prod...	The MRI system contains a component that does not meet the appropriate flame retardancy-rating w...	Class II	Canon Medical System, USA, INC.
May 21, 2021	Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI Sys...	The MRI system contains a component that does not meet the appropriate flame retardancy-rating w...	Class II	Canon Medical System, USA, INC.
May 21, 2021	Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product...	The MRI system contains a component that does not meet the appropriate flame retardancy-rating w...	Class II	Canon Medical System, USA, INC.
Feb 5, 2021	System INFX-8000V	The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc...	Class II	Canon Medical System, USA, INC.
Feb 5, 2021	System INFX-8000F	The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc...	Class II	Canon Medical System, USA, INC.
Feb 5, 2021	System INFX-8000C	The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc...	Class II	Canon Medical System, USA, INC.
Dec 8, 2020	Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization ...	System table may tilt because the bolts that fasten the vertical column and the table top tilting...	Class II	Canon Medical System, USA, INC.
Dec 8, 2020	Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization T...	System table may tilt because the bolts that fasten the vertical column and the table top tilting...	Class II	Canon Medical System, USA, INC.
Dec 8, 2020	Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization T...	System table may tilt because the bolts that fasten the vertical column and the table top tilting...	Class II	Canon Medical System, USA, INC.
Nov 11, 2020	Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A	A software problem has been identified which could result in the diagnostic imaging system not p...	Class II	Canon Medical System, USA, INC.
Nov 9, 2020	Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product...	A software problem has been identified which could result in the CT Scanner not proceeding to th...	Class II	Canon Medical System, USA, INC.
Oct 8, 2020	CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interven...	There is a potential that the cable of the Flat panel detector may break during a procedure which...	Class II	Canon Medical System, USA, INC.
Jul 8, 2020	System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Pr...	During a procedure, when images were acquired, and these images were transferred to PACS /image a...	Class II	Canon Medical System, USA, INC.
Mar 3, 2020	Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage...	Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to...	Class II	Canon Medical System, USA, INC.
Mar 3, 2020	Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage...	Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to...	Class II	Canon Medical System, USA, INC.
Mar 3, 2020	Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage...	Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion One, Model TSX-301A	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion Premium, Model TSX-301B	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion One Vision, Model TSX-301C	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion Precision, Model TSX-304A	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion Lightning, Model TSX-036A	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion Prime, Model TSX-303A	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion Prime SP, Model TSX-303B	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Mar 25, 2019	Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1	Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u...	Class II	Canon Medical System, USA, INC.
Feb 8, 2019	Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Produ...	Table tilts without operator involvement as a result of liquid spilling into tilt console trigger...	Class II	Canon Medical System, USA, INC.
Oct 16, 2018	Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version...	software malfunction; It was found when a user performs radiography using the wireless flat pane...	Class II	Canon Medical System, USA, INC.
May 30, 2018	Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a di...	When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specif...	Class II	Canon Medical System, USA, INC.
Apr 18, 2018	DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)	It was found when an operator performs a radiography using the wireless flat panel detector (FPD)...	Class II	Canon Medical System, 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.