B. Braun Medical is initiating 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 zinc oxide particulate matter.
Administration of the affected product carries a reasonable probability of causing life-threatening adverse health consequences. Potential risks include pulmonary emboli, occlusions of other blood vessels leading to tissue death and organ damage, phlebitis, systemic immune activation, organ dysfunction, and hemolysis.
The recalled product, intended for use as a source of electrolytes and water for hydration and as a diluent for intravenous drug administration, was distributed to hospitals and healthcare facilities across the U.S. between February 27, 2026, and August 3, 2026. To date, no reports of serious injury, death, or other adverse events related to this issue have been received.
Consumers who have experienced problems potentially linked to this drug product should contact their physician or healthcare provider. Questions regarding the recall can be directed to B. Braun via email at recalls@bbraunusa.com. Healthcare professionals and patients are also encouraged to report any adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.