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…
Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit Set
The recommendations provided below have 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 Product The FDA is aware that Hamilton Medical has issued…
Update on Alert: Convenience Kit Issue from Medline
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 lots have been added to the Excel sheet in the Affected Product section. Affected Product The FDA is aware that…
Intravascular Administration Set Recall: Baxter Removes Duo-Vent Solution Sets
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…
Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components
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 Medline has…
Fresenius Kabi Issues Nationwide Recall of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL Vials Due to Presence of Glass Particles
Summary Company Announcement Date: August 10, 2026 FDA Publish Date: August 11, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Glass Particles Company Name: Fresenius Kabi Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Tyenne Injection 400 mg/20 mL vial Company Announcement August 10, 2026 – LAKE…
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection
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 Medline…
Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
The affected products and recommendations for what to do with the devices below have not changed. 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…
BD Issues Nationwide Recall for Specific Lots of BD® Intraosseous Vascular Access System Needle Sets Due to Reports of Difficulty Removing the Obturator
Summary Company Announcement Date: July 30, 2026 FDA Publish Date: August 03, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to Reports of Difficulty Removing the Obturator Company Name: (Becton, Dickinson and Company) Brand Name: Brand Name(s) Product Description: Product Description Intraosseous Vascular Access System Needle Sets Company Announcement FRANKLIN LAKES,…
Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
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 Becton Dickinson (BD) has issued a letter to affected customers recommending certain Intraosseous Vascular…