FDAClass IOctober 29, 2025

Brand Name: Hemodialysis Bloodlines Product Name recall

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product…

Why was Brand Name: Hemodialysis Bloodlines Product Name 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 I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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;

Product
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product…
Recalling firm
B BRAUN MEDICAL INC
Quantity
1298454 units (1589674 - 3/5/26 Expansion)
Distribution
Domestic: US Nationwide Distribution.
Recall date
October 29, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls