Foot Controlled Electrosurgical Suction Coagulator… recallZ-0474-2023 · ConMed Corporation · initiated Nov 18, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConMed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
On November 18, 2022, the firm notified affected customers through Urgent Medical Device Recall letters. Customers were instructed to review their inventory for any of the affected product and return affected product to the CONMED. Open or used devices should not be returned. If you have any questions or requests, please contact the Field Action Support Team at 1-800-448-6506 (8:00am to 7:00pm EST Monday through Friday) or email [email protected].
Recall details
- Recall number
- Z-0474-2023
- Status
- Terminated
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Dec 9, 2022
- Recalling firm
- ConMed Corporation
- Quantity
- 23,700 US; 5,225 OUS
- Product code
- GEI
- FDA submissions
- K033003
- Distribution
- Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Product description
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Code information (models, lots, serial numbers)
UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 130187Conmed Corporation · Electrosurgical, cutting & coagulation & accessories1 recall4 reports
Other devices under the same FDA submission
1 device cleared under K033003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CONMED 130188Conmed Corporation · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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