Official recall record
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-02-26
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 20884521205441
- Brand on record
- Covidien
- Product category
- Medical Device
What the authority reported
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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