Serious riskFDA DeviceClass I

B. Braun Streamline bloodline set recalled for potential air bubbles

B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG DR. (Model SL-2010M2096A) due to a potential risk of small air bubbles accumulating in the arterial line during hemodialysis treatment. This happens when blood gases stick to the tubing under negative pressure, which could affect treatment safety. The recall affects units manufactured on or after June 9, 2025.

From the FDA notice · Read the official notice ↗ · All B. Braun recalls

What to do

  1. Stop using Model SL-2010M2096A bloodline sets immediately
  2. Contact B. Braun Medical Inc or your dialysis center for instructions on obtaining replacement bloodline sets
  3. Check your dialysis facility's inventory and notify staff if you use this product

Is yours affected?

Compare your label or packaging with the recalled product.

Product
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
3,158,104 units
Illnesses reported
None reported
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Classification
Class I
Recall number
Z-1798-2026

In the FDA's words

Description
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025 Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 3,158,104 units
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.

6 products in this recall

B. Braun hemodialysis bloodlines recalled for air bubble risk

B. Braun is recalling six hemodialysis bloodline tubing sets used during kidney dialysis. Air bubbles can build up in the arterial line because blood gases can stick to the tubing under negative pressure. No injuries have been reported, and the products were distributed across the US and Canada.

The agency lists each product separately. Check every one you might have.

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