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FDA Medical Device Recalls (openFDA)

ConMed Electrosurgery: 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.

Recall number
Z-2281-2010
Recalling firm
ConMed Electrosurgery
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.
Status
Terminated
Initiated
2008-12-18
Posted
2010-08-25
Terminated
2010-10-22
Reason
The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.
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
Dom: 46 cs (460 units); Int'l 23 cs (230 units)
Distribution
Nationwide and International
Lot, serial or model codes
Lot: 0306021 through 0806021
510(k) numbers
["K925903"]
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

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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

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