Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1390-2025 — Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

U.S. FDA — Device Enforcement · United States · 2025-02-26 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1390-2025
Date of alert
2025-02-26
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Covidien
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20884521205441
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.