FDA Medical Device Recalls (openFDA)
Conmed Corporation: ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 - Spatula, 5 mm x 32 cm; Cat #60-5158-432 - ''L'' Hook 5 mm x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm; Firm on label: ConMed Corporation, Utica, New York 13502.
- Recall number
- Z-1413-04
- Recalling firm
- Conmed Corporation
- Product
- ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 - Spatula, 5 mm x 32 cm; Cat #60-5158-432 - ''L'' Hook 5 mm x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm; Firm on label: ConMed Corporation, Utica, New York 13502.
- Status
- Terminated
- Initiated
- 2004-08-09
- Posted
- 2004-08-28
- Terminated
- 2005-10-05
- Reason
- Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
- Root cause
- Other
- Action
- Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.
- Quantity
- 1,005 units
- Distribution
- There are 127 distributors, hospitals and sales representatives in the U.S. There are 21 foreign consignees in Australia, Brazil, Canada, Costa Rica, Ecuador, Finland, India, Israel, Italy, Norway, Peru, Saudi Arabia, Spain, Turkey, United Kingdom, and Venezuela.
- Lot, serial or model codes
- Cat #60-5158-034, Lot #s 0309121; Cat #60-5158-432, Lot #s 0308071, 0309021, 0309151, 1121; Cat #60-5158-934, Lot #s 0309111;
- 510(k) numbers
- ["K960808"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- 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