Medline NON66160Recalls & reported problems
Medline Industries, Inc. · 60ML ENFIT SYRINGE, STERILE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277727304), received between Mar 15, 2024 and Jan 28, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 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
- Mechanical Problem2
- Compatibility Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Mechanical Problem
IT WAS REPORTED THAT IN "MID DECEMBER" MULTIPLE 60ML SYRINGES "WERE FOUND TO BE DEFECTIVE. THE CUSTOMER REPORTED THAT THE SYRINGES WERE "UNUSABLE" AND THAT THE "PLUNGER IS SO TIGHT IN THE HOUSING THAT IT IS DIFFICULT TO MOVE THE PISTON TO LOAD/UNLOAD THE SYRINGE." THE CUSTOMER ALSO STATED THAT THE "PLUNGER SIMPLY COMES OFF THE STEM WHILE I AM LOADING THE SYRINGE" AND "WHEN DEPRESSING THE PLUNGER." THE CUSTOMER SAID THAT IT REQUIRES "AN ENORMOUS AMOUNT OF FORCE" TO MOVE THE PLUNGER LEADING TO "LITTLE TO NO CONTROL OF THE AMOUNT BEING PROVIDED." THE CUSTOMER REPORTED THAT THEY "SWITCHED TO OTHER NON-MEDLINE SYRINGES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203486 ↗MalfunctionJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PISTON FOR THIS PRODUCT WAS DIFFICULT TO PULL BACK WHEN COMPARED TO OTHER DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19465585 ↗MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem
THE CLIENT REPORTS THAT THE PLUNGER IS HARD TO PULL BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102826 ↗MalfunctionMar 15, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PLUNGER OF THE SYRINGE WAS DIFFICULT TO PULL BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18918043 ↗
Other Enteral Syringes with enteral specific connectors devices
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- Cardinal Health 35mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall4 reports
- Cardinal Health 60mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall4 reports
- Cardinal Health 6mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Cardinal Health 12mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Cardinal Health 3mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- ENFit Syringe PNM-S60NCAvanos Medical, Inc. · Enteral Syringes with enteral specific connectors3 reports
- ENFit Syringe NM-S60NCAvanos Medical, Inc. · Enteral Syringes with enteral specific connectors1 report
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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