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
- 490025, 04046964301056, 04046964301049
- 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 deliver medications via gravity or pump systems. This recall covers PB1500 15-DROP SETS used with Infusomat Space large-volume pumps, Outlook pumps, and Vista Basic pumps.
Why This Is Dangerous
Backflow from secondary to primary IV containers and failure to prime could disrupt medication delivery and patient safety.
Industry Context
This recall is not described as part of a broader industry safety pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to identify affected lots quickly, halt use, and coordinate with providers to source replacements, potentially affecting patient treatment workflows.
Practical Guidance
How to identify if yours is affected
- Check catalog number 490025 on the device label
- Verify Primary UDI-DI 04046964301056 and Unit of Dose UDI-DI 04046964301049
- Confirm distribution region includes your facility
Where to find product info
Recall notices are accessible via the FDA enforcement page linked in this article and through the manufacturer’s recall communications
What timeline to expect
Replacement or remediation may take 4-6 weeks in hospital settings
If the manufacturer is unresponsive
- Document all communications
- Escalate through hospital procurement and patient safety officers
- File a complaint with the manufacturer and regulatory bodies if necessary
How to prevent similar issues
- Implement a vendor recall monitoring process
- Verify IV set compatibility with all pumps and gravity setups
- Maintain an up-to-date inventory of infusion sets and ensure rapid replacement options
Documentation advice
Keep the recall letter, serials/UDI data, purchase records, and all correspondence with the manufacturer and regulators.
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Product Details
Catalog Number: 490025 Primary UDI-DI: 04046964301056 Unit of Dose UDI-DI: 04046964301049 Expiration: Earliest Expiration of Component or 60 months Sold worldwide: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore Quantity: 15,250 units Product: PB1500 15-DROP IV SET W/2 STOPCOCKS Hazard: Potential for backflow of medication into primary IV containers and inability to prime Recall Date: 2025-10-29 Status: ACTIVE
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964301049
- Expiration: earliest expiry or 60 months
- Distribution: worldwide (US, Canada, Germany, Guatemala, Singapore)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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