B. Braun hemodialysis bloodlines may accumulate air bubbles in the arterial line
B. Braun is recalling one model of hemodialysis bloodline because small air bubbles can accumulate in the arterial line when blood gases adhere to the tubing under negative pressure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
B. Braun is recalling Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT, model number B3-3632M3705, primary UDI-DI 04046955348824. The action covers 4,848 units and applies to all lots manufactured since 1 August 2025.
The recall is due to the potential for the accumulation of small air bubbles in the arterial line, caused by the adherence of blood gases to the tubing under negative pressure. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, covering the United States nationwide and Canada. The bloodlines are supplied to dialysis facilities rather than sold to consumers.
Facilities should identify affected stock using the model number and UDI-DI above, quarantine it, and follow the instructions issued by B. Braun.
The recalled product
- Product
- B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
- Manufacturer
- B Braun Medical Inc
- Affected units
- 4,848
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: B3-3632M3705
- UDI-DI Primary: 04046955348824
- UDI-DI Unit: 04046955348817
- All lots manufactured since 01AUG2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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