FDA Recall of Medline's ENFIT G-TUBE Connector
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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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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