FDA Recall of Medline's ENFIT G-TUBE Connector

Source: FDA · United States and Canada

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries is recalling 651,789 units of ENFIT G-TUBE CONNECTOR due to manufacturing issues that may cause leakage, potentially leading to delayed care and fluid loss.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 15, 2026 and geographically references United States and Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

Recall Article

What Happened

Medline Industries, LP is recalling the ENFIT G-TUBE CONNECTOR because the connectors were not manufactured to required dimensional specifications, which may prevent a proper seal with ENFit-style devices and lead to leakage. This could result in delayed care, fluid loss, and additional risks if users over-tighten the connector, such as infection or patient discomfort.

Which Products Are Affected

The affected product is the ENFIT G-TUBE CONNECTOR, MEDLINE, with Item No. ENFIT1010GC. The recall involves 651,789 units, all lots, with code information UDI-DI 10888277314719 (each) and 40888277314710 (case). Distribution occurred nationwide in the United States and in Canada.

What You Should Do

Consumers who have the affected product should follow the initial firm notification, which was issued via letter, and contact Medline Industries, LP for instructions on returns or refunds. For more information, reach out to the recalling firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall affects a large number of medical devices used for patient care, potentially impacting treatment outcomes due to leakage risks, which could lead to health complications for users in the United States and Canada.

Source

This information is from the FDA recall database. For details, visit the FDA website at https://www.fda.gov and search for recall number Z-1690-2026.

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 651,789 units of ENFIT G-TUBE CONNECTOR due to manufacturing issues that may cause leakage, potentially leading to delayed care and fluid loss.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States and Canada. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.