Summary Company Announcement Date: August 05, 2026 FDA Publish Date: August 06, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage Company Name: Medline Industries, LP Brand Name: Brand…

Summary Company Announcement Date: August 05, 2026 FDA Publish Date: August 05, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated Endotoxin level Company Name: Victory Medical Center Pharmacy Brand Name: Brand Name(s) Product Description: Product Description Compounded Glutathione 200 mg/mL Multi-Dose Vials Company Announcement FOR IMMEDIATE RELEASE – August 5, 2026 –…

Summary Company Announcement Date: August 04, 2026 FDA Publish Date: August 05, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to a label mix-up Company Name: Fresenius Kabi Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL Company Announcement FOR IMMEDIATE RELEASE –…

Summary Company Announcement Date: July 31, 2026 FDA Publish Date: August 04, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass Company Name: Liebel-Flarsheim Company, LLC Brand Name: Brand Name(s) Product Description: Product Description OPTIRAY Imaging Bulk Package (IBP) 350,…

Summary Company Announcement Date: July 31, 2026 FDA Publish Date: August 03, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Visible glass fiber material in the product Company Name: American Regent, Inc. Animal Health Brand Name: Brand Name(s) American Regent, Inc. Animal Health Product Description: Product Description Adequan Canine Injection and Adequan i.m…

This is an update to an Early Alert. The affected products and recommendations for what to do with the devices below have not changed. 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…

This is an update to an Early Alert. The affected products and recommendations for what to do with the devices below have not changed. 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…

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 Product The FDA is aware that Argon…

Summary Company Announcement Date: July 24, 2026 FDA Publish Date: July 27, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain particulate matter Company Name: American Regent, Inc. Brand Name: Brand Name(s) American Regent, Inc. Product Description: Product Description Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Company Announcement…

CDRH is issuing this Early Alert to notify the public 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 ENROUTE NPS ENROUTE NPS Plus The FDA is aware that Boston Scientific has issued a letter to affected customers…