Quick Facts at a Glance
- Recall Date
- August 26, 2025
- Hazard Level
- HIGH
- Brand
- B Brau Medical Inc.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- B Brau Medical Inc.
- Product type
- Sterile Water for Injection
- Model numbers
- Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
- UPC codes
- 0264-7385, 0264-7385-50, 0264-7385-60
- Sizes
- 3000 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 26, 2025
Reported by FDA DRUG
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Sterile water for injection is used to dilute or dissolve medications for intravenous administration in hospital settings.
Why This Is Dangerous
Port misalignment can cause leakage and break sterility, risking infection if used for injection or dilution.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may experience supply disruption while ensuring sterility. Potentially requires replacement and monitoring for infection risk.
Practical Guidance
How to identify if yours is affected
- Review NDC 0264-7385-60 on the product label.
- Inspect lot numbers J3L519, J3L528, J4C522, J4C523 and expiration dates.
- Verify packaging integrity and port alignment.
Where to find product info
Recall notification letters and FDA enforce page provide details. Serial numbers and lot codes are printed on the packaging.
What timeline to expect
Refunds or replacements are determined by B. Braun policy; typical processing windows are communicated in recall notes.
If the manufacturer is unresponsive
- Escalate to FDA recall complaint process
- Seek alternative suppliers to maintain patient care
- Document all communications and times
How to prevent similar issues
- Verify port alignment during handling and administration
- Source from approved suppliers only
- Maintain inventory control to quickly quarantine recalled lots
Documentation advice
Keep recall letter, photos of labels, lot numbers, dates, and shipping documents
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Product Details
Brand: B. Braun Medical Inc. Model numbers: Lot #: J3L519, J3L528; Lot #: J4C522, J4C523. Quantity: 26,316 bags. Size: 3000 mL. Type: Sterile Water for Injection USP. Sold nationwide in the U.S. Dates: Recall date 2025-08-26. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- 26,316 total bags recalled
- Port misalignment causing potential leakage
- Class II recall
- Recall date 2025-08-26; Status: Active
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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