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
- 457515, 04046964716188, 04046964716171
- 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 are used to administer fluids and medications either by gravity or pump systems in clinical settings. They connect to IV bags or containers and feed into patients through IV catheters.
Why This Is Dangerous
Backflow can contaminate primary IV lines or doses, while occlusion can prevent proper priming and delivery of medications.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall affects hospitals and health systems worldwide. It requires immediate action to prevent potential medication administration errors and ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 457515 on the device label.
- Verify Primary UDI-DI 04046964716188 and Unit of Dose UDI-DI 04046964716171.
- Cross-check against recall notices and quarantine any affected items.
Where to find product info
FDA enforcement page for Z-0651-2026 and the BBraun Medical recall notice.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after verification of affected inventory.
If the manufacturer is unresponsive
- Document all communications with the manufacturer and facilities risk management.
- Escalate to FDA medical device recall program if the manufacturer is unresponsive or delays occur.
How to prevent similar issues
- Implement a recall-tracking process with your procurement team.
- Verify UDIs on all IV sets before use.
- Establish procedures to quarantine recalled inventory immediately.
Documentation advice
Keep the recall letter, purchase records, inventory lists, photographs of labeling (catalog and UDIs), and copies of all communications.
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Product Details
Catalog Number: 457515 Distribution: Worldwide distribution, including US and international markets (Canada, Germany, Guatemala, Singapore) Sold since: Unknown Price: Unknown Primary UDI-DI: 04046964716188 Unit of Dose UDI-DI: 04046964716171
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716171
- Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore)
- Hazard: backflow and occlusion risk
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Safety Guide
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