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…
Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels
Summary Company Announcement Date: October 01, 2026 FDA Publish Date: October 01, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential elevated endotoxin levels Company Name: Greenwich Rx Brand Name: Brand Name(s) Product Description: Product Description Glutathione Injection Company Announcement IMMEDIATE RELEASE – Tomball, Texas – October 1, 2026 – Greenwich Rx, a…
Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules
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 device may cause serious injury or death if…
Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
The affected products and recommendations for what to do with the devices below have not changed. This recall involves correcting certain devices by removing recalled components. 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…
Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters
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…
Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
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. The…
Early Alert: Ventilator Issue from React Health
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. The FDA is aware that Ventec Life Systems Inc., doing business as React Health, has issued a letter to affected…
Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter
Summary Company Announcement Date: September 18, 2026 FDA Publish Date: September 21, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as cellulose or stopper material Company Name: Par Health Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100…
Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection
Summary Company Announcement Date: September 17, 2026 FDA Publish Date: September 21, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection Company Name: Otsuka ICU Medical LLC Brand Name: Brand Name(s) ICU Medical LLC Product Description: Product Description…
Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets
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. The…