FDA-Device2026-04-22Class IPROCESSING DEFECT
B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
OTHERNationwide distribution
Stop using B. Braun hemodialysis bloodlines model B3-3632M3705
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
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.
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 Medical Inc recalls
- FDA-Device2026-04-22B. Braun StreamLine Bloodline hemodialysis tubing recalled for air bubble accumulation risk
- FDA-Device2026-04-22B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis
- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
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