Agency classClass IOur severity:Severe FDA (Devices)·Z-1802-2026·Announced 2026-04-22

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Hemodialysis bloodline
Hazard: air-embolism-risk
air-bubbles
class-i
hemodialysis
device-malfunction
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.

See all 6 products in this recall →

Same manufacturer · B Braun Medical Inc

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