Browse Device Recalls

905 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 905 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 905 FDA device recalls in 2026.

Clear
DateProductReasonClassFirm
Apr 23, 2026 Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM RE... Temperature probe devices lack FDA clearance. Class II Covidien LLC
Apr 23, 2026 Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 Temperature probe devices lack FDA clearance. Class II Covidien LLC
Apr 23, 2026 Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. Class II SSC- Surgical Specialties Corporation
Apr 23, 2026 Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the foll... The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion ... Class II Kico Knee Innovation Company
Apr 23, 2026 Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 Temperature probe devices lack FDA clearance. Class II Covidien LLC
Apr 23, 2026 Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33... Due to stain present on the surface of affected foley catheters. Class II C.R. Bard Inc
Apr 23, 2026 OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X ... Intervertebral body fusion system straight inserter failed to properly attach to affected cages, ... Class II Novapproach Spine, LLC
Apr 22, 2026 Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of th... Class II Baxter Healthcare Corporation
Apr 22, 2026 RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... Class I Bolton Medical Inc.
Apr 22, 2026 BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. Contamination to in-vitro diagnostic test may result in false positives. Class II BioFire Diagnostics, LLC
Apr 21, 2026 MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analys... Software in development inadvertently made available for customer use. Use of this software versi... Class II GE Medical Systems China Co., Ltd.
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 20, 2026 Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography... Electromagnetic contactors within high voltage generator may weld together, resulting in current ... Class II Shimadzu Medical Systems
Apr 20, 2026 Automated Impella Controller (AIC); Product Code: 0042-0000-US; A retrospective review identified that there are AIC units requiring specific hardware updates to... Class I Abiomed, Inc.
Apr 15, 2026 Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 1700... The presence of holes in the pouch may compromise the package s ability to maintain the sterile b... Class II Covidien, LP
Apr 15, 2026 COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... Due to customer complaint regarding incorrect display box labeling. Class II Covidien LLC
Apr 14, 2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 13, 2026 Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (X... Nitrile Exam Glove failed to meet specifications chemical permeation performance. Class II O&M HALYARD INC
Apr 13, 2026 LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 ... Due to a subset of chest compression systems/devices where the service performed on the systems w... Class II Jolife AB
Apr 13, 2026 LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 9957... Some defibrillators serviced between July 2023 through November 2025 were serviced without object... Class II Physio-Control, Inc.
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP

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.