Recall Z-1690-2026— Medline Industries, LP

Name: FDA recall Z-1690-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-02-13. It names one FDA 510(k) clearance: K151628. Product: 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-02-13
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K151628 — Medline ENFit ConnectorsMedline Industries, Inc.·cleared 2015-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.