FDA-Device2026-04-08Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

Medline's ENFIT G-tube connectors (Item No. ENFIT1010GC) were not made to the correct specifications and may not seal properly with ENFit-style medical devices. This can cause leakage of feeding fluids and delay necessary care. If users tighten the connector too much to stop the leak, it can cause infection, discomfort, and require additional medical treatment.

  • Stop using the affected Medline ENFIT G-tube connector immediately
  • Contact your healthcare provider or medical equipment supplier for a replacement
  • Check the item number (ENFIT1010GC) and UDI-DI 10888277314719 to confirm you have the recalled product
  • Do not attempt to over-tighten the connector 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
651,789
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2026

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