B. Braun Medical is recalling three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container, nationwide due to the presence of particulate matter identified as iron oxide. The U.S. Food and Drug Administration (FDA) announced the recall, citing a reasonable probability of life-threatening adverse health consequences from administering the affected product.
The particulate matter could lead to serious health issues such as pulmonary emboli, blockages in other blood vessels causing tissue death and organ damage, and phlebitis. Systemically, foreign particles infused intravenously may activate the immune system, cause organ dysfunction, and lead to the breakdown of blood cells. Despite these risks, B. Braun Medical has not received any reports of serious injury, death, or other adverse events related to this issue to date.
The recalled product was distributed to hospitals and healthcare facilities across the nation between February 27, 2026, and August 3, 2026. This injection is intended for use in adults and pediatric patients as a source of electrolytes and water for hydration, and as a diluent for intravenous drug administration.
Consumers who have experienced problems potentially related to this product should contact their physician or healthcare provider. Questions regarding the recall can be directed to B. Braun Medical via email at recalls@bbraunusa.com. Healthcare professionals and patients are also encouraged to report adverse events to the FDA's MedWatch program.