FDA DeviceClass IINotable

FDA Recall: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Cod

Date: 2026-07-08
Brand: Covidien LLC
Category: Medical Device
FDA Class: Class II

Description

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Hazard

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Remedy

293,659 devices

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