Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Medtronic has issued a letter to affected customers recommending certain…

Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Draeger has issued a letter to affected customers recommending certain…

Early Alert: Convenience Kit Needle Issue from Integra LifeSciences

The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Integra LifeSciences has issued a letter to affected customers recommending certain Codman Microsensor Basic Kits and Cerelink ICP Sensor…

MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.   Affected Products Product Name  Material Number UDI-DI MAGNETOM…

System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV

This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.   Affected Product Product Names: Several IMRIS Neuro III-SV models: Neuro…

Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device

Summary Company Announcement Date: December 05, 2025 FDA Publish Date: December 18, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description PolyLoop device may fail to detach as expected and become anchored to patient anatomy Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description Single use ligating device Company Announcement…

MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal Spray Due to Microbial Contamination

Summary Company Announcement Date: December 16, 2025 FDA Publish Date: December 16, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications. Company Name: MediNatura New Mexico Inc. Brand Name: Brand Name(s) ReBoost, ClearLife Product…

StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Summary Company Announcement Date: December 15, 2025 FDA Publish Date: December 16, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: StuffbyNainax LLC Brand Name: Brand Name(s) MR7 Super 700000 Product Description: Product Description Dietary supplement for male enhancement Company Announcement Huntsville, Texas — StuffbyNainax LLC is…