FDAClass IIJanuary 11, 2023

DeRoyal Tonsillectomy Tray recall

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Why was DeRoyal Tonsillectomy Tray recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

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

Product
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Recalling firm
DeRoyal Industries Inc
Quantity
320 units
Distribution
Distribution in US states of VA, and SC.
Recall date
January 11, 2023
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls