Z-0452-2008

Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110...

Name: Z-0452-2008 Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110...
Creator: ConMed Electrosurgery
Published: 2007-11-02
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2007-11-02 / Terminated / root cause: manufacturing process

FDA source

ConMed Electrosurgery began a recall of Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory... on 2007-11-02. The reason FDA records is "Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal". 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-0452-2008
Status: Terminated
Initiated: 2007-11-02
Posted: 2007-12-11
Terminated: 2010-03-31
Recalling firm: ConMed Corporation
Product: Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.
Quantity in commerce: 11,319 cases (476,160 units)
Distribution: Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay.
Product codes and lots: Part Numbers: 138100, 138101, 138102, 138103, 138104, 138105, 138107, 138110, 138112, 138113, 139100, 139107, 139108, 139112, 139321, 139104EXT, 139105EXT, 139110EXT, 139112EXT. LOT CODES: 0706211 through 0709201.

Product code GEI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)