Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-04-08
Distribution
Worldwide - US Nationwide and the countries of Canada.
Firm state
IL
Product quantity
651,789
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason 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.
Product description
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Code / lot info
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.