- Recalling firm
- Medline Industries, LP
- Reason for recall
- Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
- Affected products (lot / model / serial)
- 1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS
- Units affected
- 9,040 kits
- Distribution pattern
- Worldwide - US Nationwide and the countries of Canada.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1691-2026
- Recall initiated
- February 13, 2026
- FDA classification date
- March 27, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98524
- Last updated on HTM Vibe
- July 24, 2026