Medline ENFIT1010GCRecalls & reported problems
Medline Industries, Inc. · ENFIT G-TUBE CONNECTOR, MEDLINE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277314719), received between Apr 21, 2026 and Sep 23, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Feb 13, 2026Class IIOpen, Classified
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.
Z-1690-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Failure to Disconnect2
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Failure to Disconnect; Detachment of Device or Device Component
It was reported that "part of the connector becomes detached and the harder plastic part is almost impossible to detach from the patient's tube."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870293 ↗MalfunctionSep 21, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841713 ↗MalfunctionSep 10, 2026Failure to Disconnect; Detachment of Device or Device Component
It was reported that "We have had three separate occurrences with three different patients and three different nurses where part of the connector becomes detached and the harder plastic part is almost impossible to detach from the patient's tube."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713460 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571579 ↗MalfunctionApr 21, 2026Device Dislodged or Dislocated
CUSTOMER REPORTED, "ENFIT G-TUBE CONNECTOR WITH HARD PLASTIC INSERT PIECE WITHIN SILICONE CONNECTOR DISLODGE AND RETAINED IN GASTROTOMY OR JEJUNOSTOMY TUBES FOR (2) PATIENTS. IN BOTH CASES, THESE PIECES NEEDED TO BE REMOVED WITH KELLY CLAMPS."
Patient problems: Insufficient Information
MAUDE report 24945470 ↗MalfunctionApr 21, 2026Device Dislodged or Dislocated
CUSTOMER REPORTED, "ENFIT G-TUBE CONNECTOR WITH HARD PLASTIC INSERT PIECE WITHIN SILICONE CONNECTOR DISLODGE AND RETAINED IN GASTROTOMY OR JEJUNOSTOMY TUBES FOR (2) PATIENTS. IN BOTH CASES, THESE PIECES NEEDED TO BE REMOVED WITH KELLY CLAMPS."
Patient problems: Insufficient Information
MAUDE report 24945231 ↗
Other Enteral specific transition connectors devices
- Medline ENFIT1000TCMedline Industries, Inc. · Enteral specific transition connectors5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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