HIGH

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

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.

Quick Facts at a Glance

Recall Date
February 13, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Geographic Scope
1 states

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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Full Description

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC. 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.. Classification: Class II. Quantity: 651,789. Distribution: Worldwide - US Nationwide and the countries of Canada.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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