Recall Z-0070-2026— B BRAUN MEDICAL INC

Name: FDA recall Z-0070-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-30

Class I · Ongoing

Class I FDA medical device recall by B BRAUN MEDICAL INC, initiated 2025-09-30. It names one FDA 510(k) clearance: K080807. 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. Reason: The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors..

Recalling firm: B BRAUN MEDICAL INC
Classification: Class I
Status: Ongoing
Initiated: 2025-09-30
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K080807 — BLOOD TUBING SETS (STERILE FLUID PATH)Nxstage Medical, Inc.·cleared 2008-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

Data sourced from openFDA. This site is unofficial and independent of the FDA.