← FDA ENFORCEMENT
Z-1802-2026Class I

B Braun Medical Inc

Recalling firm
B Braun Medical Inc
Product type
Device
Status
Ongoing
Report date
2026-04-22
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Firm state
PA
Product quantity
4,848 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Product description

B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.

Code / lot info

Model Number: B3-3632M3705; UDI-DI Primary: 04046955348824; UDI-DI Unit: 04046955348817; All lots manufactured since 01AUG2025.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.