Agency classClass IIOur severity:Severe FDA (Drugs)·D-0495-2026·Announced 2026-04-29

Sterile Water for Injection bags recalled due to sterility concerns

B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class II recall of a parenteral pharmaceutical (intravenous sterile water) with a fundamental defect in assurance of sterility. Lack of sterility in injectable products poses serious risk of contamination, infection, or harm to patients, meeting the threshold for Severe classification even absent reported illnesses.

Plain-English summary

B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (Pharmacy Bulk Package, NDC 0264-7385-60) distributed nationwide. The affected product includes Lot J5H165 (expiration date 31 May 2028) and Lot J5E237 (expiration date 30 April 2028), totaling 24,928 bags.

The company identified that the product lacks assurance of sterility. Additionally, the diaphragm port may leak once the foil is removed, which could compromise product integrity.

Healthcare professionals and patients who have received this product should consult their healthcare provider if they have questions about potential exposure. The product is indicated for intravenous use and was distributed nationwide.

The recalled product

Product: STERILE WATER (WATER)
Brand: STERILE WATER
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — Injectable / Pharmacy Bulk Package
Hazard: lack-of-sterility
product-leakage
Affected units: 24,928

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 # J5H165
Exp Date: 31 May2028
Lot # J5E237
Exp Date: 30APR2028.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same brand · STERILE WATER

High
Sterile water for irrigation recalled over plastic particles from bottle rims
FDA (Drugs) · 2026-02-04
High
Sterile water for injection recalled over port misalignment allowing fluid leakage
FDA (Drugs) · 2025-09-24
High
Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations
FDA (Drugs) · 2023-03-08
High
Sterile water injection vials recalled for trace product carryover risk
FDA (Drugs) · 2023-02-01
High
Baxter Sterile Water for Injection recalled due to manufacturing defects
FDA (Drugs) · 2022-06-15

Same manufacturer · B BRAUN MEDICAL INC

See all →

Critical
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Low
B Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
Severe
B. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
Moderate
B. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Moderate
B. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10

Same hazard · lack of sterility