← FDA ENFORCEMENT
D-0869-2026Class I

B BRAUN MEDICAL INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2026-09-16
Distribution
Nationwide within the United States
Firm state
PA
Product quantity
201,472 total container
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Product description

0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.

Code / lot info

Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →