Covidien has recalled approximately 780 Shiley Adult Flexible Tracheostomy Tubes with TaperGuard Cuff Reusable Inner Cannula (REF: 7CN80R) because a part called the flange may disconnect from the main tube. This failure can cause life-threatening issues such as respiratory failure, aspiration, or severe respiratory tract infections. No injuries have been reported at this time, but the defect poses a critical risk to patient safety. Healthcare providers and facilities should stop using these devices and contact the manufacturer to arrange for returns.
The flange of the inner cannula may unexpectedly detach from the outer cannula during use. This disconnection can lead to a sudden loss of airway, difficulty breathing, or the patient inhaling device components into their lungs.
Quantity: 780 units affected; Recall #: Z-1390-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.