Shiley 9UN90ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521175751), received between Jul 6, 2026 and Jul 6, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K142296); 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.

• MalfunctionJul 6, 2026Crack

  IT WAS REPORTED THAT WHEN THE PATIENT WITHDREW THE TRACH TUBE'S INNER CANNULA FOR CLEANING, CRACK WAS FOUND IN THE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25723385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142296. One submission often covers many models, so check the product and lot details in each record.

• Z-1357-2023 · Mar 24, 2023 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CU