FDA Medical devices recall ·
Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0070-2026
- Date
- (initiated September 30, 2025)
- Company / brand
- B Braun Medical Inc
861 Marcon Blvd, Allentown, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1298454 units (1589674 - 3/5/26 Expansion)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
Why was it recalled?
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. SL-2010M2096; UDI-DI 04046964367786; Lot Numbers: A2500119, A2500121, A2500128, A2500129, A2500130, A2500132, A2500133, A2500134, A2500149, A2500150, A2500151, A2500180, A2500181, A2500182, A2500185, A2500198, A2500199, A2500200, A2500203, A2500204, A2500205, A2500206, A2500207, A2500208, A2500209, A2500210, A2500211, A2500212, A2500213, A2500214, A2500215, A2500216, A2500217, A2500218, A2500219, A2500220, A2500246, A2500247, A2500248, A2500249, A2500250, A2500251, A2500257, A2500258, A2500259, A2500260, A2500261, A2500262, A2500267, A2500268, A2500269, A2500273, A2500274, A2500275, A2500276, A2500277, A2500278, A2500295, A2500298, A2500299, A2500300; ***Addded 3/24/2026***Additional Lots Identified A2500318, A2500319, A2500320, A2500321, A2500322, A2500323, A2500324, A2500325, A2500326, A2500327, A2500328, A2500329, A2500330, A2500356, A2500357;
Distribution
Domestic: US Nationwide Distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0070-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.