FDA recall, , Moderate risk
Medline Enfit g-Tube Connector
The ENFIT G-TUBE CONNECTOR may not seal properly, leading to leakage that could cause delayed care and fluid loss.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled Medline Kits containing Enfit g-Tube Connector 1 and the Enfit G-Tube Connector because the 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 occur if a user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
The recall began on February 13, 2026, and was added to the FDA's Enforcement Report on March 27, 2026. The products were distributed nationwide in the US and in Canada. The affected products include Medline Kits containing Enfit g-Tube Connector 1 and the Enfit g-Tube Connector, MEDLINE Item No. ENFIT1010GC.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline Kits Containing Enfit g-Tube Connector 1. SKU DYKM2720 g/J Tube Care Kit 2. SKU Enfitdisckit Enfit Discharge Kit
- UDI-DI
- 10198459016257
- 40198459016258
- 10193489860078
- 40193489860079
- Lot code
- ALL LOTS
Enfit g-Tube Connector, Medline Item No. ENFIT1010GC
- UDI-DI
- 10888277314719
- 40888277314710
- Lot code
- All Lots
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide and the countries of Canada.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98524
- Recall numbers
- Z-1690-2026 to Z-1691-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
