Recall Weekly
Serious riskFDA DeviceClass I

B Braun hemodialysis bloodlines recalled for potential air bubbles

B Braun Medical Inc is recalling specific hemodialysis bloodline tubing (Model B3-4630M4705) because small air bubbles can accumulate in the arterial line when blood gases stick to the tubing under negative pressure. This could affect dialysis treatment safety. The recall affects units manufactured since August 5, 2025.

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

What to do

  1. Stop using hemodialysis bloodlines Model B3-4630M4705 immediately
  2. Check your dialysis supplies for the recalled model number on the packaging
  3. Contact your dialysis center or B Braun Medical Inc if you have this product
  4. Do not use recalled bloodlines for any dialysis treatment
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
4,884 units
Illnesses reported
None reported
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Classification
Class I
Recall number
Z-1803-2026

In the FDA's words

Description
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. 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: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 4,884 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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