Official recall notice

FDA DeviceClass IINotable

FDA Recall: ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Recall date
2026-04-08
FDA class
Class II

Why it was recalled

Hazard

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.

Recommended action

What to do

651,789

Product description

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.

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