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, PREGNANT, PREGNANT
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: 490437, Primary UDI-DI: 04046964833427, Unit of Dose UDI-DI: 04046964833410, Expiration Date: Earliest Exp of Comp or 24mths
- 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 and medications from bags or bottles to patients via IV lines. This recall concerns sets compatible with gravity and pump-driven administration.
Why This Is Dangerous
Backflow from secondary piggyback containers into primary IV lines can lead to improper dosing or contamination risk. Occlusion can prevent proper priming of the line, potentially interrupting fluid delivery.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The hazard is serious for patient safety. Healthcare facilities may need to quarantine affected inventory and implement interim controls to prevent continued use.
Practical Guidance
How to identify if yours is affected
- Review catalog number 490437 on the device label or packaging.
- Verify Primary UDI-DI 04046964833427 and Unit of Dose UDI-DI 04046964833410.
- Check expiration: earliest expiration date across components (up to 24 months).
Where to find product info
UDI-DI codes and catalog numbers are typically on the IV set package and on the product labeling.
What timeline to expect
Refund or replacement processing can take 4-8 weeks after submission, depending on supplier and location.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File complaints with your hospital supply chain and regulatory bodies if necessary.
- Consider escalation to regulatory authorities if the supplier is unresponsive.
How to prevent similar issues
- When purchasing IV sets, verify catalog numbers and UDI codes.
- Prefer products with clear backflow prevention features and positive priming performance.
- Check for updated recalls before stocking inventory.
- Maintain a robust traceability process for medical devices in use.
Documentation advice
Keep recall notice, purchase receipts, product photos, and all correspondence. Document dates of contact and responses.
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Product Details
Catalog Number: 490437 Description: IV ADMIN SET W/ 15 DROPS/ML, 118 IN. Primary UDI-DI: 04046964833427 Unit of Dose UDI-DI: 04046964833410 Expiration Date: Earliest Exp of Comp or 24mths Sold/distributed: Worldwide distribution — US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Quantity recalled: 4,536 units Recall date: 2025-10-29 Manufacturer: B. Braun Medical (BBraun Medical)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4,536 units recalled worldwide
- Unit of Dose UDI-DI 04046964833410
- Expiration: Earliest Exp of Comp or 24 months
- Backflow risk and occlusion hazard
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Safety Guide
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