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FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline ENFIT G-tube connector kits recalled for seal defect and leakage risk

Medline
OTHERNationwide distribution

Stop using Medline ENFIT G-tube connector kits

Medline Industries recalled two G-tube care kits (SKU DYKM2720 and SKU ENFITDISCKIT) because the connectors were not made to the right size. This means they may not seal properly with ENFit-style feeding tubes, which could cause leakage of nutrition or fluids. If you try to tighten the connector to stop leaking, it could cause injury, infection, or discomfort.

  • Stop using the affected Medline G-tube care kits immediately
  • Check your kit SKU numbers: DYKM2720 or ENFITDISCKIT
  • Contact Medline Industries or your healthcare provider for a replacement kit
  • Do not over-tighten the connector to try to fix leaking
Hazard

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.

Sold states
Worldwide - US Nationwide and the countries of Canada.
Affected count
9,040 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2026

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