Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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DateProductReasonClassFirm
Jan 8, 2026 Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS ... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHA... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Me... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG S... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBS... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
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 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.
Dec 18, 2025 Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... Due to product that may contain a void in the material that separates the wire guide and cutting ... Class II Wilson-Cook Medical Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 The product is used for the evaluation of the intrinsic coagulation pathway, ... Potential for microbial contamination. Class II Instrumentation Laboratory
Dec 11, 2025 Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 8155... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 3, 2025 SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Nov 6, 2025 MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) Following a component change in the DPOAE probe (speaker replacement), technical distortions may ... Class II PATH
Oct 31, 2025 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 17, 2025 Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed pos... Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... Class II TECHNO-PATH MANUFACTURING LTD.
Oct 17, 2025 Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassa... Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... Class II TECHNO-PATH MANUFACTURING LTD.
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 1, 2025 MAGNETOM Cima.X Upgrade. Model Number: 11689304. There is a potential for an ice blockage to form or currently exist within the primary and/or the... Class I Siemens Medical Solutions USA, Inc
Sep 30, 2025 IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... Class I IMPRIS Imaging Inc
Sep 30, 2025 IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet... There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... Class I IMPRIS Imaging Inc
Sep 30, 2025 IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesl... There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... Class I IMPRIS Imaging Inc
Sep 30, 2025 IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siem... There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... Class I IMPRIS Imaging Inc
Aug 28, 2025 MAGNETOM Verio Dot. Model Number: 10684333. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 BIOGRAPH One (DE). Model Number: 11689172. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Prisma. Model Number: 10849582. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Connectom.X. Model Number: 11371480. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio Dot Upgrade. Model Number: 10684334. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Cima.X (DE). Model Number: 11647158. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra fit. Model Number: 10849580. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Vida Fit. Model Number: 11410481. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Lumina (DE). Model Number: 11344916. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio. Model Number: 10276755. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 Biograph mMR. Model Number: 10433372. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Jul 25, 2025 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821... Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or other... Class II Merit Medical Systems, Inc.
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jun 30, 2025 SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 SmartPath to dStream for 3.0T Model Number (REF): 782145; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec 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.