Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- BBraun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Product type
- IV administration set
- Model numbers
- 490189, 490226
- Sizes
- 108 IN, 137 IN
- Sold at
- Unknown
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
These IV sets are used to deliver medications through gravity or pump-assisted IV systems in clinical settings.
Why This Is Dangerous
Backflow can allow medication from a piggyback container to flow into the primary container, potentially delivering a higher concentration or contamination. Occlusion can prevent proper priming of the line, disrupting flow.
Industry Context
This recall is not described as part of a broader pattern in the data.
Real-World Impact
Healthcare facilities may need to halt use of affected IV sets, potentially disrupting workflows and requiring replacements.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 490189 and 490226.
Where to find product info
UDI codes are printed on the packaging and on device labels.
What timeline to expect
Remedy delivery and replacement timelines not specified; expect recall follow-up communications.
If the manufacturer is unresponsive
- Document your contact attempts
- Escalate to hospital risk management or distributor
- Reach out to FDA or local health authority if unresolved
How to prevent similar issues
- Verify device compatibility with pumps before use
- Maintain an up-to-date device inventory with UDI codes
- Follow manufacturer recall communications promptly
- Establish a recall response protocol for clinical settings
Documentation advice
Keep recall notice, shipment receipts, and correspondence with manufacturer and healthcare providers.
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Product Details
Brand: B Braun Medical. Product: Anesthesia IV Set used with gravity and pump administration sets. Catalog numbers: 490189 (IV ADMIN SET W/15 DROPS/ML, 108 IN) and 490226 (IV ADMIN SET 137 IN). Primary UDI-DI: 04046964303586 (490189) with Unit of Use 04046964303579; Primary UDI-DI: 04046964304262 (490226) with Unit of Use 04046964304255. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Recall date: 2025-10-29. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Catalog numbers 490189 and 490226
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- High risk: backflow and occlusion
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Safety Guide
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