B. Braun recalls

B. Braun Medical Inc is recalling certain SAFSITE Injection Site valves (model RV1000NC, catalog number 415068) because they may leak or allow blood to flow backward into the IV line. This could affect the safety of IV therapy. The recall affects specific lot numbers with expiration dates in September and October 2029.

Moderate·FDA·Oct 16, 2026

B. Braun Medical Inc. is recalling specific lots of 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide, inorganic material, cellulose fibers, and polystyrene. The contamination was identified during quality testing. This is a sterile injectable product distributed nationwide.

Serious·FDA·Sep 16, 2026

Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.

Moderate·FDA·Sep 9, 2026

B. Braun Medical has recalled Lactated Ringer's Injection USP in 1000 mL EXCEL containers due to the presence of particulate matter. The affected lot is J4H077 with an expiration date of November 30, 2026. About 23,688 bags were distributed nationwide.

Serious·FDA·Sep 2, 2026

B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and healthcare settings. The recalled product contains particles of zinc oxide that should not be present. Intravenous fluids contaminated with particulate matter can cause serious complications including blood clots and organ damage. No injuries have been reported so far.

Serious·FDA·Aug 27, 2026Updated Sep 3

B. Braun Medical is recalling two lots of Lactated Ringer's Injection (1L, product code E7500) because the solution contains unwanted particles, including cellulose and stearates. If these particles enter a patient's bloodstream during use, they could cause serious complications including blood clots, tissue damage, or organ failure.

Serious·FDA·Apr 28, 2026

B. Braun is recalling six hemodialysis bloodline tubing sets used during kidney dialysis. Air bubbles can build up in the arterial line because blood gases can stick to the tubing under negative pressure. No injuries have been reported, and the products were distributed across the US and Canada.

Serious·FDA·Apr 22, 20266 products

B. Braun is recalling three models of 21-gauge winged infusion sets because the needle tip may be dull or blunt, difficult to advance, or break. The recall covers about 177,850 units distributed nationwide in the United States and in Costa Rica. No injuries have been reported.

Moderate·FDA·Mar 11, 20263 products

B. Braun is recalling 116 intravenous (IV) administration sets used with BBMI infusion pumps, including the Infusomat Space, Outlook, and Vista Basic. Medication can flow backward from secondary (piggyback) containers into primary containers, and some sets may not prime properly, which can block the flow. No injuries have been reported, and the products were distributed in the US, Canada, Germany, Guatemala, and Singapore.

Moderate·FDA·Dec 3, 2025116 products