Agency classClass IIOur severity:High FDA (Drugs)·D-0652-2025·Announced 2025-09-24

Sterile water for injection recalled over port misalignment allowing fluid leakage

B. Braun Sterile Water for Injection USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 26,316 bags are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in a sterile water product is a potential harm and no injuries are reported.

Plain-English summary

Sterile Water for Injection USP, 3000 mL, available on prescription only, from B. Braun Medical Inc. of Bethlehem, Pennsylvania, NDC 0264-7385-60, is being recalled. Affected lots are J3L519 and J3L528 expiring 31AUG2026 and J4C522 and J4C523 expiring 28FEB2027. The recall covers 26,316 bags distributed nationwide.

The recall was issued for lack of assurance of sterility, because of the potential for fluid leakage from the port due to port misalignment. The FDA classified the action as Class II.

Hospitals and pharmacies holding these lots should quarantine them, stop using them, and follow B. Braun's instructions for return or replacement.

The recalled product

Product: STERILE WATER (WATER)
Brand: STERILE WATER
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — Intravenous Solution
Hazard: sterility-assurance
container-leak
class-ii

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 (5)

Lot #: J3L519
J3L528
Exp.: 31AUG2026 Lot #: J4C522
J4C523
Exp.:28FEB2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B BRAUN MEDICAL INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · STERILE WATER

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Sterile Water for Injection bags recalled due to sterility concerns
FDA (Drugs) · 2026-04-29
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FDA (Drugs) · 2026-02-04
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Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations
FDA (Drugs) · 2023-03-08
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Sterile water injection vials recalled for trace product carryover risk
FDA (Drugs) · 2023-02-01
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Baxter Sterile Water for Injection recalled due to manufacturing defects
FDA (Drugs) · 2022-06-15

Same manufacturer · B BRAUN MEDICAL INC

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Same hazard · sterility assurance