Medline DYNJAETC35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277689497), received between Sep 14, 2026 and Sep 14, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 other recall cover devices cleared under the same FDA submission (K042683); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 14, 2026Inadequacy of Device Shape and/or Size

  It was reported that "The tubes are bigger than the standard size, the tube itself is not flexible enough to maneuver into place, the point on the end causes damage when extubated because it's so sharp, the balloon is too big to go through the vocal cords of toddlers, and if they go down a half or whole size to allow the balloon/cuff to fit then the tube itself is too short to use safely."

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50758746 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042683. One submission often covers many models, so check the product and lot details in each record.

• Z-3172-2026 · Jul 31, 2026 · Open, Classified
  SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25