Changeflow GovPing Pharma & Drug Safety Medline ENFit G-Tube Connector Recall - Type II
Priority review Enforcement Amended Final

Medline ENFit G-Tube Connector Recall - Type II

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Summary

Health Canada issued a Type II recall for Medline ENFit G-Tube Connectors (ENFIT1010GC) across all lots due to dimensional manufacturing defects. The non-compliant connectors may fail to form proper seals with ENFit devices, causing leakage and potentially delaying patient care during medication administration. Healthcare providers must identify and destroy affected products.

What changed

Health Canada issued a Type II recall for Medline ENFit G-Tube Connectors (model ENFIT1010GC) affecting all lots. The recall was initiated after determining the connectors were not manufactured to required dimensional specifications, potentially preventing proper sealing with ENFit-style devices and causing medication leakage during patient care delivery.

Healthcare providers and medical facilities using this product must immediately audit their inventory for the affected model number, remove all affected devices from use, and destroy the products according to facility protocols. Manufacturers and distributors in the supply chain should similarly identify and remove affected products from commerce to prevent further distribution of non-conforming devices.

What to do next

  1. Identify all ENFIT1010GC lots in inventory
  2. Quarantine and destroy affected connector products
  3. Contact Medline for replacement or additional information

Archived snapshot

Apr 10, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Health product recall

Medline ENFit G-Tube Connector

Brand(s)

Medline Industries, Lp

Last updated

2026-04-08

Summary

Product Medline ENFit G-Tube Connector Issue Medical devices - Device compatibility What to do Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
ENFit G-Tube Connector All lots. ENFIT1010GC

Issue

Medline ENFit G-Tube Connector (ENFIT1010GC) is recalled. This connector was not manufactured to the required dimensional specifications. Thus, the connector may not form a proper seal with ENFit style devices, so lead to leakage. This may delay the patient care, particularly during medication delivery. Customers should destroy this product.

Additional information

Details

Original published date:

2026-04-09

Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies Medline Industries, LP

Three Lakes Drive, Northfield, Illinois, United States, 60093

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-03-27

Identification number RA-81862

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Last updated

Classification

Agency
Health Canada
Filed
March 27th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81862

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Device recall response Medical device distribution Patient safety
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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