Z-1390-2025Class I

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Name: Z-1390-2025 Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Creator: Covidien
Published: 2025-02-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-02-26 / Open, Classified

FDA source

Covidien began a recall of Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R on 2025-02-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1390-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-26
Posted: 2025-03-25
Recalling firm: Medtronic, Inc.
Product: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: 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 [email protected] If you have any questions regarding this communication, contact the firm's Customer Service at 800-962-9888, Option 2.
Quantity in commerce: 780
Distribution: OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
Product codes and lots: UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1390-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25

Product code JOH

K150844Class IIShiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner CannulaCovidien / cleared 2015-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)