FDAClass IIJune 10, 2026

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner recall: Labeling Error

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing…

Why was COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner recalled?

Due to customer complaint regarding incorrect display box labeling.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX

Product
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing…
Recalling firm
Covidien LLC
Quantity
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.
Recall date
June 10, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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