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U.S. Department of Health and Human Services

Class 2 Device Recall Medline ENFit Gtube Connector

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 Class 2 Device Recall Medline ENFit Gtube Connectorsee related information
Date Initiated by FirmFebruary 13, 2026
Date PostedMarch 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1690-2026
Recall Event ID 98524
510(K)NumberK151628 
Product Classification Enteral specific transition connectors - Product Code PIO
ProductENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Code Information UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionOn 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.
Quantity in Commerce651,789
DistributionWorldwide - US Nationwide and the countries of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PIO
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