Covidien Shiley Disposable Decannulation Plug

Recall Summary Covidien LLC is recalling Shiley Disposable Decannulation Plugs distributed to hospitals, pharmacies, and laboratories in New Zealand. The manufacturer is issuing guidance about how to use the product. This is classified as a Class I recall, the most serious type.

Recalling firm
Medtronic New Zealand Limited
Product
Covidien Shiley Disposable Decannulation Plug. [Device]. Model: Covidien Shiley™ Disposable Decannulation Plug, Covidien Shiley™ Tracheostomy Tube Cuffless with Disposable Inner Cannula, Covidien Shiley™ Tracheostomy Tube Cuffed with Disposable Inner Cannula. Affected: Product number - DDCP, 4DCFN, 6DCFN, 6DFEN, 8DCFN, 8DFEN, 10DCFN, 10DFEN - All Lots
Reason
The manufacturer identified that all levels of product packaging for Covidien Shiley™ disposable decannulation plugs incorrectly display the symbol for non-DEHP: This symbol was erroneously included during the labelling creation process. The decannulation plug seal contains DEHP.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-04-23
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/fbc77de4-15ca-4434-a0b1-eb250b00c5dc