The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The affected products and recommendations for what to do with the devices below have…

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 The FDA is aware that Elevaris Medical Devices, doing business as Spectra Medical Devices, has…

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…

Summary Company Announcement Date: September 11, 2026 FDA Publish Date: September 13, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated Endotoxin level Company Name: Centric Compounding LLC Brand Name: Brand Name(s) Centric Compounding Product Description: Product Description Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune…

Summary Company Announcement Date: August 25, 2026 FDA Publish Date: August 25, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of particulate matter identified as fiberglass in the solution Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic…

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…

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…

This recall involves removing unused 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 Figure 1. Infinion CX Lead The FDA is aware that Boston Scientific has issued…

Summary Company Announcement Date: September 07, 2026 FDA Publish Date: September 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect Company Name: BMC Medical Co., Ltd. Brand Name: Brand Name(s) Product Description: Product Description Luna G3…

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 has issued a letter to affected customers recommending certain VentStar Resus Neo hoses…