DeRoyal Tonsillectomy Tray, REF 89-10698.01 recallZ-0906-2023 · DeRoyal Industries Inc · initiated Nov 28, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
DeRoyal issued an URGENT! DEROYAL RECALL NOTICE on 11/28/2022 to the distributor by email and to the end used by overnight USPS. The notice explained the problem and requested the following actions be taken: 1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or [email protected] no later than December 15, 2022. 3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email us at [email protected]. 4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer list and we will contact them.
Recall details
- Recall number
- Z-0906-2023
- Status
- Terminated
- Initiated by the company
- Nov 28, 2022
- Posted by the FDA
- Jan 5, 2023
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 320 units
- Product code
- LRO
- Distribution
- Distribution in US states of VA, and SC.
Product description
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Code information (models, lots, serial numbers)
GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-10698Deroyal Industries, Inc. · Ear, nose, and throat surgical tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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