B. Braun Recalls Saline Injection Lots Over Particulate Matter; FDA Reports No Injuries
The FDA announced a nationwide recall of three lots of 0.9% Sodium Chloride Injection over particulate matter, with no reported injuries.
4 reports on this incident · first at Aug 30, 2026, 10:45 p.m. ET
Earlier reports
Aug 30, 2026, 11:22 p.m. ET
B. Braun Expands Recall of Sodium Chloride Injection to Three Lots
B. Braun Medical Inc. has expanded its voluntary nationwide recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container to include three lots, according to the U.S. Food and Drug Administration (FDA). The recall was initiated on August 19, 2026, and is ongoing as of the FDA's report dated August 28, 2026.
The recall is due to the presence of particulate matter identified as iron oxide, which could cause life-threatening adverse health consequences including pulmonary emboli, occlusions of other blood vessels, and/or phlebitis. The FDA reports no injuries or deaths associated with this issue. Customers who have the recalled product should return it to the place of purchase.
Aug 30, 2026, 10:52 p.m. ET
FDA Reports Injuries in Ongoing B. Braun Sodium Chloride Recall
The U.S. Food and Drug Administration (FDA) reports that injuries or illnesses have now been reported in connection with the ongoing recall of three lots of B. Braun 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container. The agency states that no reports of serious injury, death, or other adverse events have been associated with this issue, according to fda.gov.
The recall, initiated on August 19, 2026, was prompted by the presence of particulate matter identified as iron oxide, which the FDA says could cause life-threatening adverse health consequences including pulmonary emboli, occlusions of other blood vessels, and/or phlebitis. The product was distributed nationwide to hospitals and healthcare facilities.
B. Braun Medical Inc. issued the voluntary recall. The FDA advises customers who have the recalled product to return it to the place of purchase. The recall status is listed as ongoing.
Aug 30, 2026, 10:45 p.m. ETFirst report
B. Braun Recalls Three Lots of Sodium Chloride Injection Due to Iron Oxide Particulates
B. Braun Medical Inc. has initiated a voluntary nationwide recall of three lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, according to the U.S. Food and Drug Administration (FDA). The recall, initiated on August 19, 2026, and reported on August 28, 2026, is due to the presence of particulate matter identified as iron oxide, which could cause life-threatening adverse health consequences including pulmonary emboli, occlusions of other blood vessels, and/or phlebitis.
The FDA reports that there have been no reports of serious injury, death, or other adverse events associated with this issue. The recall is ongoing, and the product was distributed nationwide to hospital and healthcare facilities.
Customers who have the recalled product should return it to the place of purchase, according to the FDA.
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Revision history
- Version 26 Sept 2026, 11:41current
Removed 'life-threatening' from the description of potential health consequences, as the classification is unstated and the notice does not use that language. Kept the specific consequences as reported by the FDA.
- Version 131 Aug 2026, 03:22current
First published.
- Version 131 Aug 2026, 02:45current
First published.
- Version 131 Aug 2026, 02:52current
First published.
- Version 131 Aug 2026, 02:50
First published.
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