Medline NON66201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277703667), received between Sep 21, 2026 and Sep 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K190502); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190502. One submission often covers many models, so check the product and lot details in each record.

• Z-0850-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
• Z-0849-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
• Z-0848-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
• Z-0847-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE