FDA: B. Braun Recalls Hospital IV Saline Over Metal Contamination
Three nationwide lots of 0.9% sodium chloride injection may contain iron oxide particles capable of causing life-threatening blood vessel blockages, the FDA says, though no injuries have been reported so far.
Meridians Life Desk
Published 30 August 2026 · Updated 30 August 2026 · 4 min read
HealthThe short answer
- B. Braun Medical Inc. issued a voluntary nationwide recall of three lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB container, after finding iron oxide particulate matter in the product.
- Affected lots J6B435, J6B444 and J6B457 expire April 30, 2027, and were distributed nationwide to hospitals and healthcare facilities between February 27 and August 3, 2026.
- The FDA says administering saline containing the particulate carries a reasonable probability of causing life-threatening reactions, including pulmonary emboli and blockages in other blood vessels.
- No injuries or deaths have been reported as of the recall date; healthcare facilities are told to stop using the product and return it.
B. Braun Medical has recalled three nationwide lots of 0.9% Sodium Chloride Injection after finding iron oxide particles in the saline. The FDA published the recall notice on August 28, 2026, one day after the company announced it. The affected bags went to hospitals and healthcare facilities, not to individual consumers.
What's affected
- Product: 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB (Partial Additive Bag) container, catalog number S8004-5264, NDC 0264-1800-32
- Lots: J6B435, J6B444 and J6B457, all expiring April 30, 2027
- Distributed nationwide to hospitals and healthcare facilities between February 27 and August 3, 2026
Why it matters
The FDA's notice says administering saline containing the particulate carries a reasonable probability of causing life-threatening reactions, including pulmonary emboli, blockages in other blood vessels, and phlebitis. Iron oxide particles injected into the bloodstream can also trigger an immune response or organ dysfunction, according to the notice. As of the recall date, B. Braun and the FDA say no serious injuries, deaths or other adverse events have been linked to the affected lots.
What hospitals and providers should do
Healthcare facilities are told to stop using the recalled lots immediately, quarantine remaining stock, and return it to B. Braun. Providers who administered the product to patients should watch for signs of an adverse reaction and report any issues to the FDA's MedWatch program. Facilities can reach B. Braun at recalls@bbraunusa.com, Monday through Friday, 8 a.m. to 5 p.m. Eastern.
Sources
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Meridians Life Desk is an editorial desk at Meridians, not an individual. A desk byline means the article was produced and fact-checked to that desk's published standards. Read our editorial standards and corrections policy.
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