FDA Medical Device Recalls (openFDA)
ConMed Corporation: Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
- Recall number
- Z-0474-2023
- Recalling firm
- ConMed Corporation
- Product
- Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
- Status
- Terminated
- Initiated
- 2022-11-18
- Posted
- 2022-12-09
- Terminated
- 2026-04-13
- Reason
- 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.
- Root cause
- Process control
- Action
- 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 SC130187@conmed.com.
- Quantity
- 23,700 US; 5,225 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
- Lot, serial or model codes
- UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084
- 510(k) numbers
- ["K033003"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28