Medline Industries ENFIT70503Recalls & reported problems
Medline Industries, Inc. · SET,GVTY FEEDING BG 1000ML,ENFIT,MEDLINE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884389190326), received between Sep 6, 2024 and Sep 28, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).
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
Most reported problems
Device problems
- Fluid/Blood Leak6
- Crack4
- Material Integrity Problem3
- Leak/Splash2
- Disconnection1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Feeding Problem1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Crack; Disconnection; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926336 ↗MalfunctionSep 23, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863084 ↗MalfunctionJun 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE FEEDING BAG WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627124 ↗MalfunctionJun 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE FEEDING BAG WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627119 ↗MalfunctionApr 1, 2026Fluid/Blood Leak
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE "ENTRAFLO 1000 ML GRAVITY FEEDING SET WAS NOTED TO BE LEAKING AT THE DISTAL END OF THE TUBING AT APPROXIMATELY 15:45 DURING THE FEED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757925 ↗MalfunctionApr 1, 2026Crack; Leak/Splash; Material Integrity Problem
ACCORDING TO THE CUSTOMER CONTACT ON MARCH 1ST, 2026, "ENFIT GRAVITY REFERENCE (B)(4) BAG BROKE, CRACKED AT THE TIP WHERE IT SCREWS INTO ENFIT FEMALE PART OF NG TUBE." THE CUSTOMER CONTACT REPORTED THAT THIS RESULTED IN "LEAKING OF ENTERAL FEED AT THE DISTAL END DURING USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753159 ↗MalfunctionMar 31, 2026Crack; Fluid/Blood Leak; Material Integrity Problem
ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE ENFIT GRAVITY FEED BAG CRACKED AT CONNECTION SITE, THE CONNECTION POINT TO THE NG TUBE, AND MILK LEAKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744650 ↗MalfunctionMar 30, 2026Fluid/Blood Leak
GRAVITY BAG TUBING WAS LEAKING AT CONNECTION TO NG TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716102 ↗MalfunctionMar 3, 2026Crack; Leak/Splash
GRAVITY FEED BAG LEAKING FROM CONNECTION POINT BETWEEN BAG AND TUBING (APPEARS TO HAVE TINY CRACKS IN THE PLASTIC TIP). BAG WAS USED TO PROVIDE NUTRITION VIA ENTERAL FEEDING OF FORTIFIED EXPRESSED BREAST.
Patient problems: Feeding Problem
MAUDE report 24499453 ↗MalfunctionSep 6, 2024Material Integrity Problem; Material Integrity Problem
LEAK IN THE TUBING AND BROKEN CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20162095 ↗
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- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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
- 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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