How many units are recalled and where was it distributed?

960 units recalled. Distributed worldwide including US, Canada, Germany, Guatemala, and Singapore.

What should I do if I own this product?

Stop using the product immediately. Follow the manufacturer's recall instructions. Contact BBraun Medical Inc or your healthcare provider for instructions.

Is there an injury reported linked to this recall?

No injuries or incidents are reported in the provided data.

Where can I find more information about the recall?

Refer to the FDA enforcement report Z-0686-2026 and the provided recall URL for official instructions.

Will there be a replacement or refund?

Remedy indicates stop-use and contact manufacturer for instructions. Details on replacement/refund are to be provided by BBraun Medical Inc per recall communications.

What is the product category and brand?

Brand: BBraun Medical. Product: IV Administration Set used with gravity and pump systems.

Does this impact baby or pediatric care?

The recall concerns IV administration sets used in clinical settings; pediatric use could be affected if piggyback systems apply. No specific pediatric-only impact is stated.

What is the expiration information?

Earliest expiry date of component or 36 months from manufacture.

HIGHOctober 29, 2025

BBraun Medical IV Administration Set Recalled for Backflow and Occlusion Risk (490491, 2025)

Q: What is the specific defect in the BBraun IV Administration Set 490491?

The set has a potential for backflow of medication from secondary piggyback containers into primary IV containers and an inability to prime (occlusion).

BBraun Medical Inc recalls 960 IV administration sets distributed worldwide due to backflow risk and inability to prime. The recall affects the IV administration set catalog number 490491 with UDI-DI 04046955086931. The device can allow medication to flow from secondary piggyback containers into primary IV containers and may not prime properly. Stop using immediately and follow recall instructions

Quick Facts at a Glance

Recall Date: October 29, 2025
Hazard Level: HIGH
Brand: BBraun Medical
Category: Health & Personal Care
Sold At: Unknown
At-Risk Groups: GENERAL, PREGNANT, PETS

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

This IV administration set is used to deliver medications via gravity or through IV pumps in healthcare settings.

Why This Is Dangerous

Backflow from secondary to primary IV containers can alter dosing. Inability to prime can cause incomplete administration.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

No injuries reported yet. Healthcare facilities will need to replace affected sets and monitor for potential dosing issues during IV administration.

Practical Guidance

How to identify if yours is affected

Locate Catalog Number on the device or packaging: 490491.
Verify Primary UDI-DI: 04046955086931.
Verify Unit of Dose UDI-DI: 04046955086924.
Check expiration date for earliest expiry up to 36 months from manufacture.

Where to find product info

UDI labels are typically printed on packaging and the device itself. Refer to FDA recall page for official identifiers.

What timeline to expect

Manufacturer-led remediation will determine replacement or refunds; expect 4-8 weeks for processing after request.

If the manufacturer is unresponsive

File a complaint with the FDA if the company is nonresponsive.
Document all communications and dates.
Consult hospital risk management for escalation.

How to prevent similar issues

When purchasing IV administration sets, verify UDI-DI and catalog numbers against the recall list.
Choose suppliers with current recall status and clear recall processes.
Ensure pumps are compatible with the IV set.

Documentation advice

Keep recall notification, purchase records, Photos of the device, serials/UDI, and correspondence with manufacturer.

Product Details

Product: IV Administration Set used in gravity and pump administration with BBraun Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Catalog Number: 490491. Primary UDI-DI: 04046955086931. Unit of Dose UDI-DI: 04046955086924. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 960 units. Hazard: backflow from secondary (piggyback) containers into primary containers and inability to prime.

Reported Incidents

No injuries or incidents have been reported in the provided data.

Key Facts

960 units recalled
Catalog Number 490491
UDI-DI 04046955086931
Unit of Dose UDI-DI 04046955086924
Expiration: earliest expiry date of component or 36 months

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTPETS

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeIV Administration Set

Product Details

Oct 29, 2025

BBraun Medical

Potential for