B. Braun Medical Inc. has initiated a nationwide recall of three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container, due to the confirmed presence of particulate matter. This recall affects products distributed to hospitals and healthcare facilities across the country.
The identified particulate matter includes iron oxide, inorganic substances, cellulose, or polystyrene. The administration of solutions containing such particles carries a reasonable probability of causing severe, life-threatening health consequences, such as pulmonary emboli, blood vessel occlusions leading to tissue death and organ damage, and phlebitis.
Other potential risks include systemic activation of the immune system, organ dysfunction, and hemolysis. Despite these serious risks, B. Braun Medical has reported no serious injuries, deaths, or other adverse events associated with this specific issue to date. The affected product was distributed from February 27, 2026, to August 3, 2026.
Consumers who have experienced problems potentially related to this product should contact their physician or healthcare provider. Customers with recalled product are advised to return it to the place of purchase, and B. Braun can be reached at recalls@bbraunusa.com for questions. Healthcare professionals and patients are encouraged to report adverse events to the FDA's MedWatch program.