Z-0906-2023Class II

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Name: Z-0906-2023 DeRoyal Tonsillectomy Tray, REF 89-10698.01
Creator: DeRoyal Industries Inc
Published: 2022-11-28
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2022-11-28 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Tonsillectomy Tray, REF 89-10698.01 on 2022-11-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0906-2023
Classification: Class II
Status: Terminated
Initiated: 2022-11-28
Posted: 2023-01-05
Terminated: 2026-03-18
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Tonsillectomy Tray, REF 89-10698.01
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 320 units
Distribution: Distribution in US states of VA, and SC.
Product codes and lots: GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0906-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0906-2023	Class II	Terminated	Voluntary: Firm initiated	2023-01-11	2023-01-05

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)