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Recall Observatory FDA recall evidence

Device product

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Z-1690-2026

February 13, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98524
Status
Ongoing
Classification
Class II
Quantity
651,789
Official record key
device-enforcement:Z-1690-2026

Official wording

Reason: 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.

Code information: UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots

Distribution pattern: Worldwide - US Nationwide and the countries of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.