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…
Baxter Issues Voluntary Nationwide Recall for One Lot of 70% Dextrose Injection Due to Potential Presence of Particulate Matter
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…
Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
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…
Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels
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,…
Early Alert: Breathing Circuit 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 Product The FDA is aware that Medline has issued a letter to affected customers recommending all lots of affected…
Early Alert: Portrait Core Services Software Issue from GE HealthCare
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…
Early Alert: Epidural Kit Issue from Medical Action Industries
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…
Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride 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…
B. Braun Medical Inc. Issues Voluntary North American Recall of Excel® Lactated Ringers Injection, 1000mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 19, 2026 FDA Publish Date: August 19, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene Company Name: (B. Braun) Brand Name: Brand Name(s) Product Description: Product Description…
Early Alert: Convenience Kit 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 convenience…