HIGH

B. Braun Medical IV Administration Set Recall 66,792 Units for Backflow Risk (2025)

B. Braun Medical recalled 66,792 IV Administration Sets sold worldwide through multiple healthcare distributors after reports of backflow and priming occlusion risk. The devices labeled catalog numbers 490241, 490298, and 490360 may allow medication to backflow from piggyback containers into primary lines and may fail to prime. Hospitals and clinicians should stop using immediately and follow the厂

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

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 medications and fluids through IV lines. These sets connect to primary and secondary containers and are used with infusion pumps in hospitals and clinics.

Why This Is Dangerous

Backflow can mix medication between containers, potentially altering dosing. An occlusion can prevent priming, disrupting flow and delivery.

Industry Context

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

Real-World Impact

The risk affects patients receiving IV medications. Immediate action is required to prevent potential dosing errors and interruption of therapy.

Practical Guidance

How to identify if yours is affected

  1. Check catalog numbers on packaging: 490241, 490298, 490360.
  2. Match UDIs: 04046964716447, 04046964716829, 04046964642609.
  3. Note device length: 107 in, 116 in, 119 in.

Where to find product info

UDI-DI numbers and catalog numbers are on the device packaging and product labeling.

What timeline to expect

4-8 weeks for refunds or replacements once processed by the manufacturer.

If the manufacturer is unresponsive

  • Engage hospital procurement and clinical engineering teams.
  • File a complaint with the FDA if the manufacturer is not responsive.

How to prevent similar issues

  • Verify model numbers before use.
  • Use only manufacturer-approved devices with compatible pumps.
  • Maintain an updated recall log in your facility.

Documentation advice

Keep the recall notification, photos of the affected product, and copies of all communications with the manufacturer.

Product Details

Catalog numbers: 490241, 490298, 490360. Primary UDI-DIs: 04046964716447, 04046964716829, 04046964642609. Sold worldwide through multiple healthcare distributors. US and international distribution to Canada, Germany, Guatemala, and Singapore. Price: Unknown. Sold date: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 66,792 units recalled
  • Catalog numbers 490241, 490298, 490360
  • Primary UDI-DIs: 04046964716447; 04046964716829; 04046964642609
  • UDIs correspond to 107 in, 116 in, and 119 in lengths
  • Worldwide distribution; US and international to Canada, Germany, Guatemala, Singapore
  • Hazard: backflow of medication and inability to prime

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
9/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Catalog Number 490241
Catalog Number 490298
Catalog Number 490360
Report Date
December 3, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

B. Braun Medical Recalls 21GA Winged Infusion Set (7A3842) 21,000 Units (2026)

B. Braun Medical is recalling 21,000 21GA Winged Infusion Sets (Single Pack) distributed worldwide, including Texas and Costa Rica, catalog 7A3842. The needle tip can be dull or blunt, may be difficult to advance, or break. Clinicians and patients should stop using the device and await manufacturer instructions.

B. Braun Medical
The potential
Read more
Health & Personal Care
HIGH

B. Braun Medical 21GA Winged Infusion Set 7M2802 Recalled 51,300 Units (2026)

B. Braun Medical recalls 51,300 units of its 21GA Winged Infusion Set, model 7M2802, distributed worldwide including Texas and Costa Rica. The device’s needle tip can be dull or break, making advancement difficult. Stop using the device immediately and contact the manufacturer or your healthcare provider for instructions.

B. Braun Medical
The potential
Read more
Health & Personal Care
HIGH

B. Braun Medical Recalls 32,500 Caresite Extension Sets for IV Pumps (2025)

B. Braun Medical recalled 32,500 Caresite Extension Sets used with Infusomat Space, Outlook, and Vista Basic IV pumps worldwide. The devices pose a backflow and occlusion risk in the primary IV line. Hospitals and healthcare providers should stop using the device immediately and follow the recall instructions.

B. Braun Medical
Potential for
Read more
Health & Personal Care
HIGH

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

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

B. Braun Medical
Potential for
Read more
Health & Personal Care
HIGH

B. Braun Medical IV Administration Set Recall for 129,480 Units in 2025

B. Braun Medical recalled 129,480 IV Administration Sets sold worldwide to hospitals and clinics. The devices can backflow from secondary piggyback IV containers into primary containers and cannot be primed, risking incorrect dosing. Hospitals and healthcare providers should stop using the devices immediately and follow the recall instructions from B. Braun Medical.

B. Braun Medical
Potential for
Read more
Health & Personal Care
HIGH

B. Braun Medical Anesthesia IV Set Recalled for Backflow Risk (10,536 Units) 2025

B. Braun Medical recalled 10,536 Anesthesia IV Sets sold through multiple retailers worldwide after a potential backflow from piggyback to primary IV lines and occlusion. The devices are used with Infusomat Space Large Volume Pumps, Outlook Pumps, and Vista Basic Pumps. Hospitals and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

B. Braun Medical
Potential for
Read more
Health & Personal Care
HIGH

B. Braun Medical Recalls 48-Unit IV Administration Set for Backflow Risk (2025)

B. Braun Medical recalled 48 IV Administration Sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The devices carry a backflow and occlusion risk between secondary and primary IV containers. Healthcare providers and patients should stop using immediately and follow recall instructions. A recall letter will provide further guidance on returning or replacing the 제품

B. Braun Medical
Potential for
Read more