B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter

FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron oxide, inorganic, cellulose or polystyrene particulate matter.

Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date there have been no reports of serious injury, death or other adverse events associated with this issue.

0.9% Sodium Chloride Injection USP, 100 mL is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration and is packaged in non-PVC, non-DEHP flexible container system. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

The recalled product can be identified as follows:

B Braun 
0.9% 
Sodium 
Chloride 
Injection 
USP

Product was distributed Nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026.

B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products. Customers that have the recalled product should return to place of purchase.