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DeRoyal Tonsillectomy Tray, REF 89-10698.01

FDA Recall #Z-0906-2023 — Class II — November 28, 2022

Recall #Z-0906-2023 Date: November 28, 2022 Classification: Class II Status: Terminated

Product Description

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Reason for Recall

DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

Recalling Firm

DeRoyal Industries Inc — Powell, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

320 units

Distribution

Distribution in US states of VA, and SC.

Code Information

GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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