Recall Z-1802-2026— B Braun Medical Inc

Name: FDA recall Z-1802-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Class I · Ongoing

Class I FDA medical device recall by B Braun Medical Inc, initiated 2026-03-19. It names one FDA 510(k) clearance: K080807. Product: B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.. Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure..

Recalling firm: B Braun Medical Inc
Classification: Class I
Status: Ongoing
Initiated: 2026-03-19
Firm location: Bethlehem, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K080807 — BLOOD TUBING SETS (STERILE FLUID PATH)Nxstage Medical, Inc.·cleared 2008-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.