Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
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 - Medical Devices; 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
- Product type
- IV Administration Set
- Model numbers
- 354210, 490389, 04046964182174, 04046964182167
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
IV administration sets are used to deliver fluids and medications via gravity or pump-assisted IV therapy in clinical settings.
Why This Is Dangerous
Backflow can transfer medication from a secondary line to the primary line and may prevent proper priming, risking incorrect dosing or contamination.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use of affected units, which could impact patient care and supply chains.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 354210 or 490389.
- Verify UDI-DI where available: 04046964182174 (Primary) and 04046964182167 (Unit of Dose).
- Note earliest expiration: 354210 up to 36 months; 490389 up to 24 months.
Where to find product info
Recall notice and official instructions are on the FDA recall page linked in the notice and on the manufacturer’s site.
What timeline to expect
Remedy processing and replacements typically occur within weeks to a couple of months, depending on stock and physician coordination.
If the manufacturer is unresponsive
- Escalate to your hospital risk management or procurement office.
- Document communications with the manufacturer and regulatory bodies.
How to prevent similar issues
- Verify catalog numbers and UDIs when ordering IV sets.
- Prefer suppliers that provide explicit backflow prevention features.
- Keep records of recalls and verify new shipments against updated recall notices.
Documentation advice
Retain all recall notices, purchase records, and correspondence with the manufacturer or healthcare facilities for audit and insurance purposes.
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Product Details
Catalog Number 354210: IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks. Catalog Number 490389: IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN. Sold worldwide; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 1,861,111 units. Recall Date: 2025-10-29; Report Date: 2025-12-03. Manufacturer: B. Braun Medical Inc. Remedy: Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI: 04046964182167
- Expiration: 354210 earliest exp 36 months; 490389 earliest exp 24 months
- Worldwide distribution (US, Canada, Germany, Guatemala, Singapore)
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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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