ENFit Syringe NM-S35NCRecalls & reported problems
Avanos Medical, Inc. · 35mL ENFit Syringe Orange Sterile · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770001142), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Device Contaminated During Manufacture or Shipping
NEOMED ORAL/ENTERAL SYRINGE WITH ENFIT CONNECTOR 35ML PACKAGED CONTAINED A HAIR PRIOR TO OPENING. NOTICED UPON OPENING PACKAGE. SYRINGE AND PACKAGING REMOVED FROM PATIENT ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737730 ↗
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 PNM-S60NCAvanos Medical, Inc. · Enteral Syringes with enteral specific connectors3 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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