FDA recall Z-1690-2026

Medline Industries, LP · Class II · device

Product

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

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.

Distribution

Worldwide - US Nationwide and the countries of Canada.

Key facts

Status
Ongoing
Initiation date
2026-02-13
Report date
2026-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2026