This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 Baxter Healthcare Corporation has…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 Nuwellis has issued a…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 Olympus has issued a…

Summary Company Announcement Date: December 23, 2024 FDA Publish Date: December 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles may contain empty capsules. Company Name: Astellas Pharma US, Inc. Brand Name: Brand Name(s) Product Description: Product Description Tacrolimus and Tacrolimus Extended-Release capsules Company Announcement FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec….

Summary Company Announcement Date: December 21, 2024 FDA Publish Date: December 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Fungal Contamination Company Name: Alcon Laboratories Brand Name: Brand Name(s) Product Description: Product Description Lubricant Eye Drugs Company Announcement FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is…

This recall involves updating instructions for using 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 following the updated instructions. Affected Product Product Names:…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 Trokamed has issued a…

Summary Company Announcement Date: December 20, 2024 FDA Publish Date: December 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is an unapproved drug. Company Name: Endo, Inc. Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) Company Announcement MALVERN, PA, December 20, 2024…

Summary Company Announcement Date: December 16, 2024 FDA Publish Date: December 18, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared Metformin and Glyburide Company Name: Shoppers-Plaza Brand Name: Brand Name(s) Product Description: Product Description SugarLin Herbal Formula Herbal Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – December 16, 2024 –…

This recall involves removing 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 Product Names: BioZorb Marker and BioZorb LP Marker Product Codes: NEU Product Part Numbers: F0405 BioZorb…