FDA early alert: selected B. Braun Dialog+ bloodlines
Published November 4, 2026 · Coverage October 25–31, 2026, Pacific · High priority
FDA’s device-safety listing identifies an October 27 early alert for selected B. Braun Streamline Bloodline Sets for the Dialog+ hemodialysis system. The later-viewed FDA alert identifies model SL-2010M2096 and lots A2600099, A2600128 and A2600136. FDA describes a potentially inadequately bonded dialyzer connector that could detach or leak during priming or dialysis, risking blood loss or interrupted treatment. FDA says to ensure all users are informed and to identify and quarantine affected devices. Its description of B. Braun’s October 20 letter says to inform users, have distributors forward the notice to consignees, determine inventory, stop use, quarantine and return affected product to the manufacturer.
Applicability and suggested action: Dialysis and supply-chain teams should compare their inventory with the current FDA alert and complete manufacturer notice. The FDA page was reviewed November 2 and identifies the manufacturer’s October 20 notice; the complete notice was not separately available. This is a later observation, not an archived October 31 page version.
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