FDA Device recall Z-1803-2026
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705
- FDA Device
- Class I
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class I recall of B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705 by B Braun Medical, citing potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1803-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Reason
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Identifiers
| code_info | Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by B Braun Medical
- 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18…
FDA Drug · Class I · 2026-09-16 · B Braun Medical - Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
FDA Device · Class II · 2026-09-09 · B Braun Medical - Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-77…
FDA Drug · Class I · 2026-09-02 · B Braun Medical - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Produc…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SS…
FDA Device · Class I · 2026-06-10 · B Braun Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1803-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.