Agency classClass IOur severity:Critical FDA (Drugs)·D-0869-2026·Announced 2026-09-16

B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide and fibers.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) as it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container. The recall affects 201,472 total containers distributed nationwide within the United States. The specific lots involved are J6B435, J6B444, and J6B457, all with an expiration date of April 30, 2027.

The recall was initiated because particulate matter was identified in the product. The identified particles include iron oxide, inorganic material, cellulose cotton fiber, or polystyrene. This is a Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Healthcare providers and patients should stop using the affected lots of Sodium Chloride Injection immediately. Consumers should check their medication inventory for the specific lot numbers and expiration dates listed above. If you have questions about this recall, contact B. Braun Medical Inc. or your healthcare provider for guidance on proper disposal or replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — IV Solution
Hazard: particulate-matter
contamination
Affected units: 201,472

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

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