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Recall Observatory FDA recall evidence

Device product

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT

Z-1691-2026

February 13, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98524
Status
Ongoing
Classification
Class II
Quantity
9,040 kits
Official record key
device-enforcement:Z-1691-2026

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: 1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (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.