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 Avid Medical has issued a letter to affected customers recommending certain convenience kits affected…

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 AVID Medical…

Summary Company Announcement Date: August 25, 2026 FDA Publish Date: August 26, 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 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic…

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 stainless steel particles in the solution. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description 70% Dextrose Injection, USP in 2000 mL…

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 NOxBOX has issued a letter to affected customers recommending certain nitric oxide delivery systems…

Summary Company Announcement Date: August 19, 2026 FDA Publish Date: August 20, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated Endotoxin level Company Name: Optimal Balance Pharmacy Brand Name: Brand Name(s) Optimal Balance Pharmacy Product Description: Product Description Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial Company Announcement FOR IMMEDIATE RELEASE – August 19,…

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 Medline has issued a letter to affected customers recommending all lots of 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 GE HealthCare has issued a letter alerting affected customers of updated use instructions…

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 Medical Action Industries has issued a letter to affected customers recommending certain epidural kits be…

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…