Browse Device Recalls

1,683 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,683 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 1,683 FDA device recalls in 2026.

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DateProductReasonClassFirm
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 navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navif... Due to complaints received for the Image Management System regarding image/metadata discrepancy w... Class II Ventana Medical Systems, Inc.
Apr 20, 2026 Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 ... Due to a software coding issues for calculating the implant orientation diagram printout for the ... Class II Staar Surgical AG
Apr 20, 2026 Allia IGS 7 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS 5 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia Moveo angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS 3 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
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 16, 2026 Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Numbe... It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not... Class II The Binding Site Group, Ltd.
Apr 15, 2026 Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH ... A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument ... Class II Fresh Roast Systems 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 Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: ... Due to incorrect incubation process being performed on product. Class II HF Acquisition Co LLC
Apr 13, 2026 Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: ... Due to incorrect incubation process being performed on product. Class II HF Acquisition Co LLC
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
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
Apr 10, 2026 Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... Class II Medline Industries, LP
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
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
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
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.