Stop using now Drug recall · FDA · Published August 26, 2025

B Braun Medical 3000mL IV Fluid Recall: Risk of Contamination from Port Leakage

B Braun Medical recalls 3000mL 0.9% sodium chloride irrigation solution due to potential contamination from port leakage. Affected lots expire Feb 2027. Stop using immediately to prevent infection risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0653-2025Drug B Braun Medical ›

Stop using this now

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Take action

Contact the company

Recalling firmB BRAUN MEDICAL INC861 Marcon Blvd · Allentown, PA 18109-9577

✎ GovInfoNow plain-language explainer

B Braun Medical is recalling 3000mL 0.9% sodium chloride irrigation solutions that could leak from the port, risking contamination. This is a serious safety issue for medical use requiring immediate action. Read more at govinfonow.com/recall/31853-b-braun-medical-3000ml-iv-fluid-recall-risk-of-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/31853-b-braun-medical-3000ml-iv-fluid-recall-risk-of-contamination · Updated August 17, 2026 · FDA enforcement record: FDA #D-0653-2025

Cite this page

“B Braun Medical 3000mL IV Fluid Recall: Risk of Contamination from Port Leakage.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31853-b-braun-medical-3000ml-iv-fluid-recall-risk-of-contamination. Based on FDA recall #D-0653-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2025%22&limit=1).

B Braun Medical Inc. voluntarily recalled 0.9% Sodium Chloride Irrigation USP bags due to potential fluid leakage and lack of sterility assurance, the FDA said on Aug. 26, 2025. The company initiated the Class II recall after identifying port misalignment issues in specific lots.

How to tell if you have it

Brand: B Braun Medical
Product: 0.9% Sodium Chloride Irrigation USP. Isotonic Solution for Irrigation, 3000mL
NDC: 0264-7388-60
Lot codes: J4C521, J4C516, J4C524
Expiration date: 28FEB2027
Quantity: 16,228 bags
Distribution: U.S. Nationwide

The hazard

The recall addresses a lack of assurance of sterility and the potential for fluid leakage from the port due to port misalignment. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show B Braun Medical Inc. has 66 other recalls on record since Oct. 15, 2013. Recent brand recalls include a 2026-08-19 recall for particulate matter in 100mL Sodium Chloride Injection and a 2026-08-12 recall for particulate matter in Lactated Ringer's Injection. Other recent recalls of similar products include an Oct. 27, 2025 Otsuka ICU Medical IV fluid recall for potential container leaks and a Dec. 22, 2025 Baxter Sterile Water for Irrigation recall for plastic particles.

How to tell if you have this one

Check for the product name '0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL' with the lot numbers J4C521, J4C516, or J4C524. The expiration date is February 2027.

Brand
B Braun Medical
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
U.S. Nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0652-2025	STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.; Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027	26,316 3000 mL bags	0264-7385-50, 0264-7385-60
D-0653-2025	0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.; Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.	16,228 3000 mL bags	0264-7388-50, 0264-7388-60

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the affected solution to prevent potential contamination during medical procedures.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

Aug 26, 2025Firm started the recall
Sep 16, 2025FDA classified it Class II
Sep 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31853-b-braun-medical-3000ml-iv-fluid-recall-risk-of-contamination">B Braun Medical 3000mL IV Fluid Recall: Risk of Contamination from Port Leakage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0653-2025 (August 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0653-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.