DeRoyal Tonsillectomy Tray recalled for potential suction port occlusion
DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with no reported injuries or illnesses. The hazard—suction port occlusion preventing device function—qualifies as a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High (3).
Plain-English summary
DeRoyal Industries Inc is recalling certain lots of its Tonsillectomy Tray (REF 89-10698.01), a surgical procedure pack containing a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall affects 320 units distributed in Virginia and South Carolina.
ConMed received reports indicating that suction ports on affected devices may be occluded (blocked). If occlusion occurs, the devices will not be able to perform the suction function during use, which could impact suctioning during tonsillectomy procedures.
The affected lots are: 57466936 (expires 8/1/2026) and 57897761 (expires 6/1/2026), with GTIN 50749756373222. Healthcare facilities that received these products should stop using them and contact DeRoyal Industries Inc for instructions on return or replacement. No injuries or illnesses have been reported.
The recalled product
- Product
- DeRoyal Tonsillectomy Tray, REF 89-10698.01
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN 50749756373222
- Lots: 57466936 exp 8/1/2026
- Lot 57897761 exp 6/1/2026
Distribution
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