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
- Catalog Number: 490551, Primary UDI-DI: 04046955275304, Unit of Dose UDI-DI: 04046955275298
- 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 connect IV bags or bottles to patients and include tubing and a pump-compatible interface. This product is used in gravity and pump-assisted administration.
Why This Is Dangerous
Backflow can send medication from a piggyback line into the primary line, and occlusion can prevent proper priming of the line, potentially delivering an incorrect dose or compromising sterility.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using these sets may face supply interruptions and protocol changes. The recall emphasizes patient safety and proper line priming.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490551 on the product label or packaging.
- Check Primary UDI-DI 04046955275304 on the label.
- Check Unit of Dose UDI-DI 04046955275298.
Where to find product info
UDI codes and catalog numbers are printed on the device and packaging.
What timeline to expect
Recall processing and replacements may take 4-8 weeks once initiated.
If the manufacturer is unresponsive
- Document all contacts with the manufacturer.
- Escalate to hospital compliance or the FDA if the issue is not resolved.
How to prevent similar issues
- Verify UDI codes before use or purchase.
- Avoid unapproved suppliers and verify recall status via FDA resources.
- Ensure devices are labeled for correct pump compatibility and backflow protection.
Documentation advice
Retain recall letter, take photos of the product and labels, save correspondence with the manufacturer.
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Product Details
Catalog Number: 490551 Length: 127 inches Description: IV Administration Set for gravity IV administration and pump systems with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump Global distribution: US, Canada, Germany, Guatemala, Singapore Expiration: Earliest Exp of Comp or 36 months Recall date: 2025-10-29 Status: ACTIVE UDI references: Primary UDI-DI 04046955275304; Unit of Dose UDI-DI 04046955275298
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955275298
- Exp: earliest expiry or 36 months
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Safety Guide
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