Quick Facts at a Glance
- Recall Date
- August 26, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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. Braun Medical Inc.
- Product type
- Isotonic saline irrigation
- Model numbers
- J4C521, J4C516, J4C524
- UPC codes
- 0264-7388, 0264-7388-50, 0264-7388-60
- Sizes
- 3000 mL
- Sold at
- Multiple Retailers
- 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
0.9% Sodium Chloride Irrigation USP is used for sterile irrigation in medical settings. It is sold as 3000 mL bags for Rx use.
Why This Is Dangerous
The port misalignment can lead to leakage and potential breach of sterility, posing infection or contamination risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to quarantine affected lots while awaiting guidance; patients may experience delays in sterile irrigation care.
Practical Guidance
How to identify if yours is affected
- Check NDC 0264-7388-60 on packaging.
- Look for models J4C521, J4C516, J4C524.
- Confirm 3000 mL bag size and Rx-only labeling.
Where to find product info
Recall notice letters and FDA enforcement report D-0653-2025.
What timeline to expect
Refunds or replacements will be handled via notification by mail; processing timelines vary.
If the manufacturer is unresponsive
- Document all communications
- Escalate to manufacturer or FDA if no response after a reasonable period
- Consider alternative suppliers with verified sterility
How to prevent similar issues
- Verify sterility assurances from supplier
- Use only products with intact sterile packaging
- Maintain inventory controls to isolate recalled lots
- Follow hospital procurement protocols to ensure traceability
Documentation advice
Keep recall notification letter, photos of packaging, lot numbers, and correspondence with vendor
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Product Details
Product: 0.9% Sodium Chloride Irrigation USP Isotonic Solution for Irrigation, 3000 mL, Rx only. Brand: Sodium Chloride for Irrigation. NDC: 0264-7388-60. Models: J4C521, J4C516, J4C524. Quantity: 16,228 bags. Sold nationwide in the U.S. by unknown distributors. Status: Active recall as of 2025-09-24. Manufacturer: B. Braun Medical Inc., Bethlehem, PA 18018, USA.
Reported Incidents
No incidents or injuries are reported in the provided data.
Key Facts
- Port misalignment risk
- Nationwide distribution in the U.S.
- Class II recall
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Safety Guide
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