Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- 490488, 490492, 490503
- Sizes
- 126 in, 132 in, 139 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
IV administration sets deliver fluids via gravity or infusion pumps. The three catalog numbers differ in length and labeling.
Why This Is Dangerous
Backflow from secondary to primary containers and occlusion can lead to incorrect dosing or contamination of IV fluids.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to replace affected sets; potential for dosing errors if backflow occurs; no injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers on labeling for 490488, 490492, or 490503.
- Record the length and the 15 drops/mL specification to confirm the model.
Where to find product info
Refer to the labeling on the device and packaging. FDA recall page lists catalog numbers and UDIs.
What timeline to expect
4-8 weeks for refunds or replacements, depending on supplier and facility processes.
If the manufacturer is unresponsive
- File a recall complaint with the FDA if the manufacturer is slow to respond.
- Coordinate with your hospital purchasing or supplier to escalate.
How to prevent similar issues
- Verify catalog numbers before stocking IV sets.
- Source from approved suppliers with recall monitoring.
- Check UDI-DI on new stock before patient use.
Documentation advice
Save the recall notification, take photos of the product label, keep all correspondence with manufacturer and supplier.
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Product Details
Catalog Number 490488 — 126 in; IV Admin Set W/15 DROPS/ML. Catalog Number 490492 — 132 in; IV Admin Set W/15 DROPS/ML. Catalog Number 490503 — 139 in; IV Admin Set W/15 DROPS/ML. Primary UDI-DI for 490488: 04046955086870; Unit of Dose UDI-DI: 04046955086863. Primary UDI-DI for 490492: 04046955086757; Unit of Dose UDI-DI: 04046955086740. Primary UDI-DI for 490503: 04046955135714; Unit of Dose UDI-DI: 04046955135707. Expiration: Earliest Exp of Component or 24 months (490488); Earliest Exp of Component or 36 months (490492, 490503).
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 187,464 units recalled worldwide
- 15 drops per mL
- Lengths 126 in, 132 in, 139 in
- Hazard: backflow and occlusion risk in IV administration sets etc. Replacement available; refunds or
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Safety Guide
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