Shiley Adult Tracheostomy Tube (Covidien) – Flange Disconnect Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Brand
Covidien
Lot Codes / Batch Numbers
UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029
Products Sold
UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029
Covidien is recalling Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R due to Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respirator. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 2/26/2025, recall notices were mailed and/or emailed to Risk Managers, Directors of Respiratory Care, Anesthesiology, Pulmonary/Intensive Care and ENT who were asked to do the following: 1) For patients with affected devices currently in place, a replacement is required. The patient's medical team should assess the overall patient risk when considering the timing of replacement. Clinicians should continue to follow current product Instructions For Use (IFU) along with facility specific policies and procedures. 2) Quarantine and return all unused product from the affected lot in your inventory to the firm. 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lot has been transferred or distributed. 4) Complete and return the enclosed Customer Confirmation Form via email to rs.gmbmitgfca@medtronic.com If you have any questions regarding this communication, contact the firm's Customer Service at 800-962-9888, Option 2.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026