Recall archive / FDA device enforcement
DeRoyal Tonsillectomy Tray, REF 89-10698.01 — FDA record Z-0906-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DeRoyal Tonsillectomy Tray, REF 89-10698.01
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 320 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0906-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution in US states of VA, and SC.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 11, 2023
- Recall initiation date
- Nov 28, 2022
- Center classification date
- Jan 5, 2023
- Termination date
- Mar 18, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.