Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannulasee related information
Date Initiated by FirmApril 15, 2026
Date PostedMay 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2261-2026
Recall Event ID 98813
510(K)NumberK812302 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductCOVIDIEN 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.
Code Information Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
FEI Number 2936999
Recalling Firm/
Manufacturer		 Covidien LLC
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information ContactTechnical and Clinical Support
800-255-6774 Ext. 6
Manufacturer Reason
for Recall		Due to customer complaint regarding incorrect display box labeling.
FDA Determined
Cause 2		Process control
ActionOn 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 rs.gmbmitgfca@medtronic.com even if they do not have unused inventory. For questions - contact Medtronic Representative or Customer Service at 800-962-9888.
Quantity in Commerce1,002
DistributionWorldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JOH
-
-