Agency classClass IIOur severity:High FDA (Devices)·Z-0474-2023·Announced 2022-12-21

Electrosurgical Suction Coagulator Devices Recalled Due to Potential Suction Port Blockage

ConMed's electrosurgical suction coagulator devices may have blocked suction ports that prevent proper function during procedures. Affected devices could cause procedure delays and require alternative equipment.

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: FDA Class II recall affecting a surgical suction device. No illnesses or injuries have been reported, but suction port occlusion creates a risk-of-harm scenario where the device could fail during use and require procedure delays or alternative equipment.

Plain-English summary

ConMed Corporation is recalling its Foot Controlled Electrosurgical Suction Coagulator devices (Catalog Number 130187, 10FR model). Approximately 23,700 units were distributed in the United States, and 5,225 units were distributed to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.

The recalled devices may have occluded (blocked) suction ports. When a suction port becomes blocked, the device cannot perform its suction function during procedures. This could cause delays in surgical procedures and may require alternative equipment to be used.

This is an FDA Class II recall. No patient illnesses or injuries have been reported. Affected devices can be identified by their catalog number (130187) and specific lot codes: 202204294, 202205134, 202205164, 202206084, 202206154, 202206204, 202206304, 202207074, 202207084, 202208014, 202208044, and 202208084 (UDI-DI: 30653405059930).

Healthcare facilities and clinicians should stop using affected devices and contact ConMed Corporation for replacement or repair. Additional details and instructions are available from the FDA.

The recalled product

Product: Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Manufacturer: ConMed Corporation
Category: Medical Device — Surgical / Electrosurgical
Hazard: device-malfunction
suction-failure

Distribution

Distributed nationwide across the United States.

Same manufacturer · ConMed Corporation

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