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
- 490088, 490107
- 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 solutions to patients and are used with gravity or pump-based delivery systems. They are critical for precise dosing and safe medication administration.
Why This Is Dangerous
Backflow from secondary to primary IV lines and incomplete priming can alter delivered doses and risk patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals and clinics may need to replace affected sets promptly; potential delays in therapy if devices are in use.
Practical Guidance
How to identify if yours is affected
- Identify catalog numbers 490088 and 490107 on the product label.
- Check expiration dates if visible; earliest expiry allowed per label.
Where to find product info
Refer to the FDA recall page linked in the article and contact B. Braun Medical Inc for instructions.
What timeline to expect
Remediation will be guided by manufacturer communications and hospital supply chains; replacement or repair timelines will be provided by the company.
If the manufacturer is unresponsive
- Escalate via hospital risk management or procurement contact.
- Request assistance from B. Braun Medical Inc through official recall channels.
How to prevent similar issues
- Verify device catalog numbers and UDIs before deployment.
- Work with suppliers to confirm recall status before purchase.
- In future, confirm that devices are within recall status before installation.
Documentation advice
Keep the recall notice, product labels, UDIs, and correspondence with the manufacturer for records.
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Product Details
Catalog numbers: 490088 and 490107. UDI-DI: 04046964301889 (490088) and 04046964302145 (490107). Unit of Dose UDI-DI: 04046964301872 (490088) and 04046964302138 (490107). Expiration: earliest expiry of component or up to 60 months. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Two catalog numbers: 490088 and 490107
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow risk and occlusion potential
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Safety Guide
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