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

FDA device recall Z-1691-2026 · posted 2026-03-27 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

Action taken

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

Status

Open, Classified

Product code

PIO

Quantity affected

9,040 kits

Distribution

Worldwide - US Nationwide and the countries of Canada.

Date initiated

2026-02-13

Date posted

2026-03-27

Location

Northfield, IL