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Open, Classified

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

FDA Recall Z-1691-2026 · Posted 2026-03-27

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodePIO
Date Initiated2026-02-13
Product Quantity9,040 kits

Reason 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.

Firm Action

On February 13, 2026, the firm notified affected consignees via Urgent Medical Device Recall letters delivered through First Class mail and email. Customers were instructed to destroy all affected ENFit G-Tube connectors and kits that contain the G-Tube connectors.

Root Cause

Process change control

Distribution Pattern

Worldwide - US Nationwide and the countries of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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