FDA Medical devices recall ·
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula recall
- Recall number
- Z-2261-2026
- Date
- (initiated April 15, 2026)
- Company / brand
- Covidien, LP
6135 Gunbarrel Ave, Boulder, CO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,002
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to customer complaint regarding incorrect display box labeling.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
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.
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2261-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.