B BRAUN MEDICAL INC: Device Recall

Recall #Z-0070-2026 · 09/30/2025

Class I: Dangerous

Recall Details

Recall Number: Z-0070-2026
Classification: Class I
Product Type: Device
Recalling Firm: B BRAUN MEDICAL INC
Status: Ongoing
Date Initiated: 09/30/2025
Location: Allentown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1298454 units

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.

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

Distribution Pattern

Domestic: US Nationwide Distribution.

Other Recalls by B BRAUN MEDICAL INC

Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

View all recalls by B BRAUN MEDICAL INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.