Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Cata...

FDA Device Recall #Z-0474-2023 — Class II — November 18, 2022

Recall Summary

Recall Number Z-0474-2023
Classification Class II — Moderate risk
Date Initiated November 18, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ConMed Corporation
Location Utica, NY
Product Type Devices
Quantity 23,700 US; 5,225 OUS

Product Description

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

Reason for Recall

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.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.

Lot / Code Information

UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084

Other Recalls from ConMed Corporation

Recall # Classification Product Date
Z-1498-2021 Class II INFINITY_TRAY Custom Procedural Kit - Canada. ... Mar 26, 2021
Z-1499-2021 Class II KIT_INFINITY_BASE Custom Procedural Kit - Italy... Mar 26, 2021
Z-0650-2021 Class II Infinity ACL Tibial Elbow Guide-indicated for u... Nov 12, 2020
Z-0651-2021 Class II Infinity ACL Tibial Tip Guide- indicated for u... Nov 12, 2020
Z-1305-2019 Class II ConMed Anchor Tissue Retrieval System 15 MM, 15... Mar 21, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.