ENFit Syringe PNM-S60NCRecalls & reported problems
Avanos Medical, Inc. · 60mL ENFit Syringe Purp Sterile · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770001173), received between Feb 6, 2026 and May 19, 2026 — classified as 3 malfunctions.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026
KNOWN MANUFACTURING DEFECT - CAPS WILL NOT STAY ON SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215892 ↗MalfunctionMay 19, 2026
CAP FOR 60ML ENTERAL FEEDING SYRINGE DOES NOT STAY ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215832 ↗MalfunctionFeb 6, 2026
SYRINGE CAPS THAT COME IN PACKAGE DO NOT STAY ON SYRINGE. APPEARS THAT CAPS ARE NOT THREADED, SO THEY JUST POP RIGHT OFF, THUS NOT PROTECTING ENTERAL FEEDING CONTENTS. THESE HAVE BEEN FOUND OVER MULTIPLE DAYS/SHIFTS OVER THE PAST WEEK AND A HALF. THERE IS A WIDE VARIETY OF LOT NUMBERS AFFECTED, BUT NOT ALL SYRINGE CAPS IN EACH LOT ARE FAULTY. ONLY 60 ML SYRINGES APPEAR TO BE AFFECTED. ([REDACTED] LOT# TY250712. BUT AGAIN, HAVE SEEN THIS ISSUE WITH SEVERAL LOT NUMBERS: TY250712, TY250802, TY250809, TY250725, TY250801).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277913 ↗
Other Enteral Syringes with enteral specific connectors devices
- Cardinal Health 1mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall5 reports
- 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
- Medline NON66160Medline Industries, Inc. · Enteral Syringes with enteral specific connectors4 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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