FDA Medical Device Recalls (openFDA)
ConMed Electrosurgery: * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE ***** LOT 09GHL001 July 2014 MADE IN CHINA ** CONMED CORPORATION 525 FRENCH RD, UTICA, NY USA 13502"
- Recall number
- Z-0165-2010
- Recalling firm
- ConMed Electrosurgery
- Product
- * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE ***** LOT 09GHL001 July 2014 MADE IN CHINA ** CONMED CORPORATION 525 FRENCH RD, UTICA, NY USA 13502"
- Status
- Terminated
- Initiated
- 2009-09-30
- Posted
- 2009-11-10
- Terminated
- 2010-03-16
- Reason
- One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
- Root cause
- Process control
- Action
- Recalling firm notified all distributors by phone from 9/30 - 10/1/09. All customers were notified by letter titled "URGENT: DEVICE RECALL" dated 09/30/2009 on 10/2/2009. Customers were instructed to check their inventory for the affected product, complete the reply form and return affected product. For questions, please contact Damaris Velez or Jeff Dickinson of ConMed Electrosurgery at 800-552-0138, ext 5225 or email succoagrecall AT conmed.com.
- Quantity
- 2700 units
- Distribution
- US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA
- Lot, serial or model codes
- Lot #: 09GHL001
- 510(k) numbers
- ["K052104"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004491689
- Firm city
- Centennial
- Firm state
- CO
- 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