Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brands
- BBraun Medical, B Braun Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 - 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
- BBraun Medical, B Braun Medical
- Product type
- IV Administration Set
- Model numbers
- 490528, 490550, 490605, 490616, 490654
- 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 deliver fluids via gravity or pump systems. They are essential in hospitals and clinics for controlled medication delivery.
Why This Is Dangerous
Backflow can cause unintentional dosing or contamination of the primary line. Occlusion prevents proper priming and flow.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk to patients if backflow occurs; impacts hospital workflows and patient safety.
Practical Guidance
How to identify if yours is affected
- Review UDIs: Primary 04046955203284 for 490528, etc.
- Look for expiration dates up to 36 months from manufacture
Where to find product info
UDI-DI on packaging and product labels; catalog numbers printed on tubing sets
What timeline to expect
Recall effectiveness will depend on provider replacements; refunds/replacements may take weeks to months
If the manufacturer is unresponsive
- Document all outreach attempts
- Escalate to hospital risk management
- Contact BBraun Medical Inc customer service
How to prevent similar issues
- Verify compatibility with Infusomat Space, Outlook, and Vista Basic pumps before use
- Monitor for backflow signs during infusion
- Ensure priming procedures are followed
- Keep an updated log of device lot numbers
Documentation advice
Retain recall notice, order numbers, and replacement documentation; photograph labels
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: IV Administration Set. Catalog numbers: 490528, 490550, 490605, 490616, 490654. Distributed worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 190,625 units. Brands: B Braun Medical Inc. Models/UDIs aligned with catalog numbers and expirations listed below.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Primary UDI-DI 04046955203284 for 490528; Unit of Dose UDI-DI 04046955203277; Expiration up to 36m
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.