FDA-Device2026-04-08Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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
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The agency's original wording
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.

Intended for
All ages
Illnesses reported
None reported
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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