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 Covidien 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

Lot, batch or date codesProduct Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX

Quantity recalled1,002

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.

Nationwide Texas

Questions about this recall

Is Shiley Tracheostomy Tube Cuffed with Inner Cannula recalled?

Yes. Covidien recalled Shiley Tracheostomy Tube Cuffed with Inner Cannula on 15 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2261-2026.

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 21 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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