What is the recall about?

The recall concerns BBraun Medical IV administration sets catalog 490239 used with Infusomat Space, Outlook, and Vista Basic pumps. It cites a risk of backflow and occlusion preventing priming.

Which products are affected?

IV administration sets with Catalog Number 490239 and UDIs 04046964716423 and 04046964716416 are affected.

What should I do if I own this product?

Stop using it immediately and follow manufacturer recall instructions. Contact B Braun Medical Inc for guidance.

How will I get a replacement or refund?

Follow the recall notice for instructions on return or replacement.

Where can I find more information?

FDA enforcement page and recall notification links are provided in the recall notice.

Is there a timeline for resolution?

The recall status is active as of December 2025; specific timelines for replacement are not listed here.

Who is the manufacturer?

B Braun Medical Inc, a brand operating in the medical device sector.

What systems are affected?

Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.

How is the recall classified?

Class II recall with high hazard potential due to misadministration risks.

HIGHOctober 29, 2025

B Braun Medical IV Administration Set Recall: 5,100 Units Distributed Worldwide Over Backflow and Oc

Q: Are there any injuries reported?

No injuries or incidents are mentioned in the provided data.

Q: What is the hazard?

Potential backflow from secondary (piggyback) IV containers into primary IV containers and an occlusion that prevents priming.

B Braun Medical Inc. recalls 5,100 IV administration sets distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. The recall cites backflow of medication from piggyback containers into primary IV containers and an occlusion that prevents priming. Patients should stop use immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date: October 29, 2025
Hazard Level: HIGH
Brands: BB Braun Medical, B Braun Medical
Category: Health & Personal Care
Sold At: Unknown
At-Risk Groups: GENERAL, PREGNANT, PREGNANT

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

IV administration sets are used to deliver fluids and medications via intravenous tubing. These sets connect to IV bags or bottles and may be used with automated pumps.

Why This Is Dangerous

Backflow can cause unintended dosing or contamination. Occlusion can prevent proper priming, risking under-delivery or over-delivery of medications.

Industry Context

This recall is not part of a broader industry pattern; it highlights specific device-set compatibility and backflow/occlusion risks.

Real-World Impact

High risk for incorrect dosing and potential contamination if backflow occurs. Timely replacement is essential to maintain safe IV administration.

Practical Guidance

How to identify if yours is affected

Check Catalog Number: 490239 on the IV administration set barrel.
Check UDIs: 04046964716423 (Primary), 04046964716416 (Unit of Dose).
Check Expiration: Earliest expiration date per component or 24 months from manufacture.

Where to find product info

UDI labels and catalog numbers on the packaging and on the IV set tubing itself.

What timeline to expect

Replacement or refund timeline to be provided by BBraun Medical Inc; expect weeks to months depending on stock and process.

If the manufacturer is unresponsive

Document all contact attempts.
Escalate to FDA recall contact if no response after 30 days.
Consider legal guidance for medical device recalls if timely remedy is not provided.

How to prevent similar issues

Verify device compatibility with pumps before use.
Check for recall notices from FDA/BBraun before procurement.
Maintain records of lot numbers and UDIs for every IV set purchased.

Documentation advice

Keep recall notice, photos of product, purchase receipts, and correspondence with manufacturer.

Product Details

Catalog Number: 490239. Primary UDI-DI: 04046964716423. Unit of Dose UDI-DI: 04046964716416. Expiration: earliest expiration of component or 24 months. Quantity: 5,100 units. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore.

Reported Incidents

No specific injuries or incidents are mentioned in the provided data. The status is active and hazard level HIGH.

Key Facts

5,100 units recalled
Catalog Number 490239
UDI-DI 04046964716423
Unit of Dose UDI-DI 04046964716416
Expiration: earliest expiration or 24 months
Worldwide distribution: US, Canada, Germany, Guatemala, Singapore

View Original Recall on FDA - Medical Devices

Browse More Recalls

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTPREGNANTPREGNANTINFANTSCHILDRENELDERLYPETS

Injury Types

ELECTRICALLACERATIONPOISONINGSUFFOCATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeIV Administration Set

Product Details

Brands

BB Braun Medical B Braun Medical

Related Recalls

Health & Personal Care

HIGH

B Braun Medical 490202 Extension Set Recall: 13,600 Units Over Backflow Risk (2025)

B Braun Medical Inc recalled 13,600 extension set units used with Infusomat Space and related pumps sold through multiple healthcare distributors worldwide. The recall cites a backflow risk from secondary piggyback containers into primary IV containers and an inability to prime due to occlusion. Healthcare providers and facilities should stop using the device immediately and follow manufacturer-re

Oct 29, 2025

B Braun Medical

Potential for

Health & Personal Care

HIGH

B. Braun Medical Extension Set Recall Covers 300 Units for Backflow, Occlusion Risk (2025)

B. Braun Medical Inc. recalls 300 extension sets used with Infusomat Space and other pumps. The recall flags potential backflow from piggyback IV containers into primary IV containers and the inability to prime. Hospitals should stop using the device immediately and follow recall instructions.

Oct 29, 2025

B Braun Medical

Potential for

Health & Personal Care

HIGH

B. Braun Medical Recalls 554,015 SafeDAY IV Sets Over Backflow Risk (2025)

B. Braun Medical recalled 554,015 SafeDAY IV administration sets distributed worldwide on Oct 29, 2025. The devices can backflow medication from secondary piggyback containers into primary IV containers and may fail to prime. Hospitals and clinics should stop using the affected sets and follow the manufacturer’s recall instructions.

Oct 29, 2025

B Braun Medical

Potential for

Health & Personal Care

HIGH

B Braun Medical Extension Set Recall for IV Pumps Recalled Worldwide Over Backflow and Occlusion Haz

B Braun Medical recalls 61,423 extension sets used with Infusomat Space, Outlook, and Vista pumps. The recall cites a potential backflow from secondary to primary IV lines and an inability to prime. Stop using the device immediately and follow recall instructions from the manufacturer.

Oct 29, 2025

BB Braun Medical

Potential for

Health & Personal Care

HIGH

B Braun Medical Recalls 18,984 IV Administration Sets Over Backflow Hazard

B Braun Medical recalled 18,984 IV administration sets after discovering a potential for backflow of medication from secondary IV containers into primary containers. This defect creates a high risk of medication errors and occlusion. Patients and healthcare providers should stop using these sets immediately and contact B Braun Medical for further instructions.

Oct 29, 2025

B Braun Medical

Potential for

Health & Personal Care

HIGH

B. Braun Medical Infusion Extension Set Recall for 11,650 Units Over Backflow Risk (2025)

B. Braun Medical recalls 11,650 extension sets used with Infusomat Space pumps sold worldwide after a backflow and priming defect. The device can allow medication to flow from a piggyback container into the primary line and may not prime properly. Hospitals and patients should stop using the device immediately and follow recall instructions from the manufacturer.

Oct 29, 2025

B Braun Medical

Potential for

Health & Personal Care

HIGH

B Braun Medical Extension Set Recalled for 1,200 Units Over Backflow and Occlusion Risk (2025 Recall

B Braun Medical recalled 1,200 extension sets used with Infusomat Space large-volume pumps distributed worldwide to hospitals and clinics. The recall cites potential backflow from secondary IV containers into primary containers and an inability to prime (occlusion). Healthcare facilities should stop using the devices immediately and follow the recall instructions issued by the manufacturer.

Oct 29, 2025

B Braun Medical

Potential for

Health & Personal Care

HIGH

B. Braun Medical Anesthesia IV Set Recall for Backflow Risk in 2025 (58,752 Units)

B. Braun Medical recalled 58,752 Anesthesia IV Sets used with Infusomat Space pumps and other BBMI devices. The recall targets backflow from secondary piggyback IV containers to primary containers and occlusion. Hospitals and clinicians should stop using the device immediately and await manufacturer guidance by recall letter.

Oct 29, 2025

B Braun Medical

Potential for