- Recalling firm
- B Braun Medical Inc
- 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.
- Affected products (lot / model / serial)
- Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025.
- Units affected
- 1,174,271 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- Firm location
- Bethlehem, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1800-2026
- Recall initiated
- March 19, 2026
- FDA classification date
- April 15, 2026
- FDA report date
- April 22, 2026
- FDA event ID
- 98552
- Last updated on HTM Vibe
- July 24, 2026