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Shiley 9CN90RRecalls & reported problems

Covidien LP · Adult Flexible Tracheostomy Tube with TaperGuard (TM) Cuff Reusable Inner Cannula · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K150844); 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.

Recalls naming this device

  1. Mar 24, 2023Open, Classified

    A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

    Z-1357-2023 · Root cause: Component change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

  • Z-1390-2025 · Feb 26, 2025 · Open, Classified
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.