Z-2281-2010

ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica...

Name: Z-2281-2010 ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica...
Creator: ConMed Electrosurgery
Published: 2008-12-18
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2008-12-18 / Terminated / root cause: manufacturing process

FDA source

ConMed Electrosurgery began a recall of ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502... ASSEMBLED IN MEXICO ABC PROBE REF... on 2008-12-18. The reason FDA records is "The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units". 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-2281-2010
Status: Terminated
Initiated: 2008-12-18
Posted: 2010-08-25
Terminated: 2010-10-22
Recalling firm: ConMed Corporation
Product: ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502... ASSEMBLED IN MEXICO ABC PROBE REF 160636 5 mm Handswitching Probe, 44 cm QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.
Quantity in commerce: Dom: 46 cs (460 units); Int'l 23 cs (230 units)
Distribution: Nationwide and International
Product codes and lots: Lot: 0306021 through 0806021

Product code GEI

K925903Class IILaparoscopic 5Mm Abc Probe, ModificationBirtcher Medical Systems, Inc. / cleared 1992-12-30

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)