BETHLEHEM, Pa. — A Pennsylvania-based company on Wednesday issued a voluntary recall of a common intravenous fluid used by medical facilities to replace lost water and body salts.
According to a company announcement posted on the U.S. Food and Drug Administration website, B. Braun Medical Inc., of Bethlehem, is voluntarily recalling one lot of Excel Lactated Ringers Injection, which was distributed nationally and to Canada.
The company announcement states that the 1,000-millileter solution, which was distributed to facilities at the hospital healthcare level, was recalled due to the presence of “particulate,” or tiny matter.
The matter was identified primarily as cellulose cotton fibers, with other individual particles revealed as cellulose wood fiber and polystyrene.
B. Braun Medical Inc. Issues Voluntary North American Recall of Excel® Lactated Ringers Injection, 1000mL Due to the Presence of Particulate Matter https://t.co/YTWKS2q0l8 pic.twitter.com/r5ZUxO0xyX
— U.S. FDA Recalls and Alerts (@FDArecalls) August 20, 2026
“The use of the defective product has a reasonable probability of causing 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),” B. Braun said in a statement. “Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells).”
The lot number was listed as J4H077 and had an expiration date of Nov. 30, 2026.
B. Braun reported that so far, the company has not received reports of any adverse events related to the recall.
The product is used as a source of water and electrolytes for hydration and fluid replacement and may be administered to adult, pediatric and neonatal patients based on clinical need, the notice stated.
The product was distributed from Aug. 29, 2024, through Sept.30, 2024.
B. Braun is notifying its distributors and customers by mail and is arranging for the return and replacement of all recalled products.
Customers in possession of the recalled product shoud return it to the point of sale, the company said.
Consumers with questions about the recall can contact B. Braun by emailing the company at recalls@bbraunusa.com, Mondays through Fridays from 8 a.m. to 5 p.m. ET.
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