FDA Issues Recall for Saline Bags Over Fiberglass Concerns
Baxter International has voluntarily recalled two lots of its 0.9% Sodium Chloride Injection after concerns that the intravenous saline may contain fiberglass particles. The U.S. Food and Drug Administration published the recall notice, which applies to 500 mL plastic bags distributed to healthcare providers and distributors in 14 states from July 31 through August 3, 2026.
The affected products carry lot numbers Y495523 and Y495523A and expire on October 31, 2027. Baxter advised healthcare facilities to identify and remove the recalled bags from use. Intravenous saline is routinely used to treat dehydration, deliver medications and support patients during medical procedures.
According to the FDA, injecting particulate matter into the bloodstream can lead to serious medical complications. Fiberglass or other contaminants may irritate veins, cause inflammation, worsen existing infections or trigger allergic reactions. Particles may also obstruct blood vessels or promote clotting, potentially reducing blood flow to vital organs. Possible outcomes include pulmonary embolism, permanent organ damage or death.
Baxter said it had received no reports of adverse events linked to the two recalled saline lots as of August 25, 2026. The absence of reported injuries does not eliminate the stated risk, and the recall is intended to prevent affected products from being administered.
The saline recall follows two other Baxter recalls involving injectable products and possible particulate contamination. One concerned a lot of anticoagulant sodium citrate solution that may contain fiberglass, while another involved a 70% dextrose injection that may contain stainless steel particles. Together, the actions reflect several recent cases involving possible foreign material in injectable medical solutions, although each recall applies to identified lots, not every unit of the products. Healthcare providers and distributors should review inventory, including lot numbers and expiration date, to ensure that affected saline bags are removed from circulation and not administered to patients.