CLASS I ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report

B. Braun Hemodialysis Bloodlines recalled by B Braun Medical

B Braun Medical is recalling B. Braun Hemodialysis Bloodlines, Streamline Bloodline Set For Dialog, distributed nationwide in the US. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.

Quantity recalled2,653,711 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1799-2026
FDA event ID: 98552
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class I
Status: Ongoing
Recall initiated: 19 Mar 2026
FDA classified: 15 Apr 2026
Reported: 22 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Mar 2026	Recall initiated by company
15 Apr 2026	Classified by FDA	+27 days
22 Apr 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Product as listed by the FDA

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Is B. Braun Hemodialysis Bloodlines, Streamline Bloodline Set For Dialog recalled?

Yes. B Braun Medical recalled B. Braun Hemodialysis Bloodlines, Streamline Bloodline Set For Dialog on 19 Mar 2026. The recall is Class I and its status is Ongoing. Recall number Z-1799-2026.

Why was it recalled?

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Which lots are affected?

Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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