Z-2261-2026Class II

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices...

Name: Z-2261-2026 COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices...
Creator: Covidien LLC
Published: 2026-04-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-04-15 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LLC began a recall of COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access... on 2026-04-15. FDA classified it as Class II and gives the reason as "Due to customer complaint regarding incorrect display box labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2261-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-15
Posted: 2026-05-29
Recalling firm: Medtronic, Inc.
Product: COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Due to customer complaint regarding incorrect display box labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/15/2026, the firm sent via mail/email an "Urgent Medical Device Recall" Letter to customers informing them that due to a manufacturing process packaging error, correctly manufactured and labeled individual units of the Covidien Shiley" cuffed fenestrated adult tracheostomy tube with reusable inner cannula were inadvertently placed into incorrect display boxes. A customer report indicating that the product display box is incorrectly labeled as item code 6CFN, which corresponds to cuffless devices. The correct item code is 6FEN, and it appears correctly on all other labeling, including the outer carton labels and device tray label. Customers are instructed to: 1. Quarantine all unused product from the affected lot of Covidien Shiley" cuffed fenestrated adult tracheostomy tube with reusable inner cannula. 2. Return all unused product from the affected lot in their inventory to Medtronic, as described in the Customer Confirmation Form. 3. Share this notice with all relevant personnel within their organization, and with any organization to which the potentially affected product from the specified lot has been transferred or distributed. 4. Complete and return the enclosed Customer Confirmation Form to [email protected] even if they do not have unused inventory. For questions - contact Medtronic Representative or Customer Service at 800-962-9888.
Quantity in commerce: 1,002
Distribution: Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
Product codes and lots: Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2261-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code JOH

K812302Class IIShiley Fenestrated Low Press. CuffedShiley, Inc. / cleared 1981-09-08

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)