FDANovember 28, 2022device
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
deroyal
UPCs
50749756373222
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)2026-05-18
- FDADeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement2025-01-31
- FDADeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement2025-01-15
- FDADeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.062024-10-03
- FDADeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-062024-10-03
- FDADeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-062024-10-03
- FDADeRoyal C-SECTION TRACEPACK, REF 89-9338-062024-10-03
- FDAGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART2024-02-13
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