FDA-Device2022-12-21Class II
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Hazard
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Sold states
Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Affected count
23,700 US; 5,225 OUS
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0474-2023More ConMed Corporation recalls
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts during laparoscopy
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert malfunction
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert risk
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts
- FDA-Device2026-06-24ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
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