CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
Shiley Tracheostomy Tube Cuffed with Inner Cannula recalled by Covidien
Covidien is recalling Shiley Tracheostomy Tube Cuffed with Inner Cannula, distributed nationwide in the US. The recall was initiated on 15 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2261-2026
- FDA event ID
- 98813
- Recalling firm
- Covidien, Boulder, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Apr 2026
- FDA classified
- 29 May 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 15 Apr 2026 | Recall initiated by company | |
| 29 May 2026 | Classified by FDA | +44 days |
| 10 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to customer complaint regarding incorrect display box labeling.
Product as listed by the FDA
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.
Where it was distributed
Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
Questions about this recall
Why was it recalled?
Due to customer complaint regarding incorrect display box labeling.
Which lots are affected?
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
Where was it sold?
Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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