What is recalled and why?

B. Braun Medical recalled 19,320 Anesthesia IV Sets used with BBMI pumps due to the potential for backflow from secondary to primary IV containers and inability to prime, which could affect patient safety.

Which products are affected by the recall?

Anesthesia IV Sets with Catalog Number 490476 and related BBMI devices used with Infusomat Space and other BBMI pumps.

How many units are involved in the recall?

19,320 units are involved in this recall distributed worldwide through healthcare facilities.

What should I do if I have this product?

Stop using the product immediately and follow the manufacturer’s recall instructions. Contact B. Braun Medical Inc. or your healthcare provider for further guidance.

Where can I find more information or a remedy?

Refer to the FDA recall page and the manufacturer’s recall notice for instructions and potential replacement options.

Will there be a refund or replacement?

The recall notice states to follow manufacturer instructions. Replacement or remedy details will be provided by the manufacturer to affected facilities.

Who is affected by this recall?

Healthcare facilities and patients using these IV sets with BBMI pumps globally, including US, Canada, Germany, Guatemala, and Singapore.

What is the primary hazard?

Backflow of medication from secondary piggyback containers into the primary IV container and an inability to prime the line.

How will I know when the recall is complete?

Updates will come from the manufacturer and regulatory agencies. Check the FDA recall page for status updates.

HIGHOctober 29, 2025

B. Braun Medical Recalled 19,320 Anesthesia IV Sets for Backflow Risk (2025)

Q: How do I identify if my device is affected?

Check for Catalog Number 490476 and the Primary UDI-DI 04046964958953, Unit of Dose UDI-DI 04046964958946 on the device package or labeling.

B. Braun Medical Inc. recalled 19,320 Anesthesia IV Sets used with Infusomat Space Large Volume Pumps and related BBMI devices sold worldwide through healthcare facilities. The devices pose a backflow risk from secondary piggyback IV containers into the primary IV container and cannot be primed. Healthcare facilities and patients should stop using the device immediately and follow the manufacturer

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

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

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About This Product

The product is an anesthesia IV set used in gravity and pump-based IV administration with BBMI pumps. It is used in hospital settings to deliver medications and fluids intravenously.

Why This Is Dangerous

Backflow from piggyback to primary IV containers and occlusion during priming can lead to incorrect dosing or lack of delivery of meds.

Industry Context

This recall is not indicated as part of a broader industry pattern in the provided information.

Real-World Impact

Hospitals and clinics may need to quarantine affected lots and replace devices to ensure safe IV administration, potentially affecting operations and procurement timelines.

Practical Guidance

How to identify if yours is affected

Locate Catalog Number 490476 on packaging or labeling.
Record Primary UDI-DI 04046964958953 and Unit of Dose UDI-DI 04046964958946.
Confirm the device is listed in the recall notice.

Where to find product info

Recall notice and FDA enforcement page provide identifiers and instructions.

What timeline to expect

Recall processing and replacements are managed by the manufacturer; timelines vary by facility and inventory levels.

If the manufacturer is unresponsive

Escalate to hospital risk management.
Document all correspondence and keep copies of recall notices.
Consider contacting regulatory agencies if manufacturer support is slow.

How to prevent similar issues

Verify UDI codes during purchasing and inventory checks.
In future purchases, ensure supplier recall status is reviewed before acceptance.
Keep a centralized log of all recall notices and actions.

Documentation advice

Keep the recall notice, hospital communications, and replacement records. Photograph labeling and UDI-DI cards for audit.

Product Details

Catalog Number: 490476; Primary UDI-DI: 04046964958953; Unit of Dose UDI-DI: 04046964958946. Distribution: Worldwide distribution including US, Canada, Germany, Guatemala, and Singapore. Quantity: 19,320 units. Sold through healthcare facilities to hospitals and clinics.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Quantity recalled: 19,320 units
Catalog Number: 490476
Primary UDI-DI: 04046964958953
Unit of Dose UDI-DI: 04046964958946
Recall status: Active
Hazard: backflow and occlusion risk

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeAnesthesia IV Set (IV Administration Set for gravity and pump use)

Product Details

May 7, 2026

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