B Braun Hemodialysis Bloodlines — Class I medical device recall Z-1803-2026
Ongoing recall by B Braun Medical Inc, reported 2026-04-22, distributed nationwide. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to th
| Recall number | Z-1803-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-04-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4,884 units |
| UPC / GTIN / UDI-DI | 04046955348831, 04046955348848 |
| Model numbers | B3-4630M4705 |
Product
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1803-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.