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 The FDA is aware that Abiomed has issued an Urgent Medical Device Recall (Correction) notice to affected customers recommending…

The affected products and recommendations for what to do with the devices below have not changed. 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…

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 The FDA is aware that Draeger, Inc. has issued a letter to affected customers recommending certain anesthesia Machine be…

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. This is an update to an Early Alert; the affected products and recommendations have not changed. Affected…

Summary Company Announcement Date: May 13, 2026 FDA Publish Date: May 13, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of glass particles Company Name: Sun Pharmaceutical Industries, Inc. Brand Name: Brand Name(s) Product Description: Product Description DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Company Announcement FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON,…

Summary Company Announcement Date: May 08, 2026 FDA Publish Date: May 12, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Contaminated with Staphylococcus aureus. Company Name: Pharmacal Brand Name: Brand Name(s) Product Description: Product Description Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube Company Announcement – May/8/2026- Jackson, WI, Pharmacal is…

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. This is an update to an Early Alert; the affected products and recommendations for what to do…

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. The affected products and recommendations for what to do with the devices below have not changed. Affected…

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 The FDA is aware that Boston Scientific…

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. This is an update to an Early Alert; the affected products below have not changed. The recommendations…