FDA-Device2026-04-22Class IPROCESSING DEFECT
B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
What this means
B. Braun Medical Inc is recalling specific hemodialysis bloodline tubing because small air bubbles can accumulate in the arterial line during dialysis treatment. This happens when blood gases stick to the tubing when negative pressure is applied. The affected units were manufactured on or after August 1, 2025.
- Check if your hemodialysis bloodlines match model number B3-3632M3705
- Contact your dialysis center or B. Braun immediately if you have this product
- Do not use these bloodlines; ask your care team for a replacement
- Keep the product packaging to confirm the model and lot number
The agency's original wording
Hazard
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
4,848 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1802-2026More B. Braun recalls
- FDA-Device2026-09-09B Braun Discofix Four Way Stopcock recalled for incorrect expiration date
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