FDA Issues Class II Recall for Sodium Chloride Irrigation Solution Due to Particulate Contamination

The US Food and Drug Administration (FDA) has announced a Class II recall of 0.9% Sodium Chloride Irrigation USP, packaged in 500 mL plastic irrigation containers (PIC) and manufactured by B. Braun Medical Inc., due to the presence of particulate matter. The recall affects 32 256 bottles from Lot #J4K936, with an expiration date of July 31, 2027. This voluntary recall was initiated by the company on March 31, 2025, after internal quality checks identified the contamination. Distribution includes 12 distributors who may have further circulated the product nationwide.

The recalling firm, B. Braun Medical Inc., located in Irvine, California, notified consignees by letter. The FDA officially classified the recall as Class II on April 8, 2025, indicating that exposure to the affected product may cause temporary or medically reversible adverse health consequences, but the likelihood of serious injury is remote. No public press release has been issued, but pharmacists and health care providers are urged to review their inventory, identify affected lots, and remove any impacted containers immediately to prevent potential harm during surgical or wound irrigation procedures.

This product is used as an isotonic irrigation solution for flushing wounds, surgical sites, or body cavities. The presence of particulate matter can pose risks such as local irritation, infection, or embolism, particularly when used in delicate clinical settings.