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
- 490245, 04046964716508, 04046964716492
- 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 bags or piggyback containers to patients. They are used with gravity feeds or infusion pumps. The labeled catalog 490245 specifies 15 drops per milliliter and 133 inches of tubing.
Why This Is Dangerous
A backflow scenario occurs when medication from a piggyback container re-enters the primary IV line. An occlusion may prevent priming, hindering proper administration of IV fluids or medications.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use of affected sets, replace stock, and re-train staff on device selection and infusion procedures.
Practical Guidance
How to identify if yours is affected
- Look for Catalog Number 490245 on the IV set labeling.
- Confirm labeling indicates 15 DROPS/ML and 133 IN.
- Check Primary UDI-DI 04046964716508.
- Check Unit of Dose UDI-DI 04046964716492.
- Verify expiration date per component or the 36-month maximum shelf life.
Where to find product info
Refer to the FDA recall page Z-0676-2026 and manufacturer recall communications for instructions and replacement options.
What timeline to expect
The recall notice does not specify a replacement or refund timeline.
If the manufacturer is unresponsive
- Document all outreach attempts with the manufacturer and your healthcare facility.
- Escalate to hospital risk management or patient safety officers.
- File a consumer product safety complaint if you believe health risks persist.
How to prevent similar issues
- Verify catalog numbers and UDIs before ordering IV administration sets.
- Use only sets from authorized suppliers and verify pump compatibility.
- Monitor for recall notices from manufacturers and the FDA.
Documentation advice
Keep the recall letter, packaging, UDIs, and purchase records. Save all correspondence with the manufacturer. Photograph affected labeling for records.
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Product Details
Catalog Number: 490245; Label: IV ADMIN SET W/15 DROPS/ML, 133 IN.; Primary UDI-DI: 04046964716508; Unit of Dose UDI-DI: 04046964716492; Distribution: Worldwide; US distribution and international to Canada, Germany, Guatemala, Singapore; Sold since: Unknown; Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716492
- Distribution: Worldwide to US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow and occlusion
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