B. Braun Hemodialysis Bloodlines Recalled Due to Potential Air Bubble Accumulation
B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG (Model Number: SL-2010M2096) because air bubbles may accumulate in the arterial line.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The product is subject to an FDA Class I recall, which is the most serious classification.
Plain-English summary
B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG, Model Number: SL-2010M2096. This recall affects approximately 2,653,711 units distributed nationwide in the US and Canada.
The recall was initiated because small air bubbles may accumulate in the arterial line. This occurs due to blood gases adhering to the tubing under negative pressure.
Users should follow manufacturer instructions regarding the use of these bloodlines.
The recalled product
- Product
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
- Manufacturer
- B Braun Medical Inc
- Affected units
- 2,653,711
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: SL-2010M2096
- UDI-DI Primary: 04046964367786
- UDI-DI Unit: 04046964367779
- All lots manufactured since 25MAY2025.
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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