Class I — B BRAUN MEDICAL INC
| Recalling firm | B. BRAUN MEDICAL INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. |
| 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 |
| Quantity | 1298454 units (1589674 - 3/5/26 Expansion) |
| Distribution | Domestic: US Nationwide Distribution. |
| Initiated | 2025-09-30 |
| Classified | 2025-10-22 |
| Recall number | Z-0070-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — B BRAUN MEDICAL INC (Z-0070-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97609/
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