- 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)
- UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
- Units affected
- 651,789
- 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-1690-2026
- 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