Z-0165-2010

* (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION...

Name: Z-0165-2010 * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION...
Creator: ConMed Electrosurgery
Published: 2009-09-30
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2009-09-30 / Terminated / root cause: manufacturing process

FDA source

ConMed Electrosurgery began a recall of * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE ***** LOT 09GHL001... on 2009-09-30. The reason FDA records is "One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0165-2010
Status: Terminated
Initiated: 2009-09-30
Posted: 2009-11-10
Terminated: 2010-03-16
Recalling firm: ConMed Corporation
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"
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Lot #: 09GHL001

Product code GEI

K052104Class IIUltraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled SuctionConmed Corporation / cleared 2005-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)