FDA Medical Device Recalls (openFDA)
Conmed Corporation: ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
- Recall number
- Z-1301-04
- Recalling firm
- Conmed Corporation
- Product
- ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
- Status
- Terminated
- Initiated
- 2004-06-28
- Posted
- 2004-07-31
- Terminated
- 2005-10-05
- Reason
- Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.
- Root cause
- Other
- Action
- Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.
- Quantity
- 3,252 units
- Distribution
- Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.
- Lot, serial or model codes
- Cat. #60-5158-034 with lot #s 0310301, 0402031, 0403051, 0404131; Cat. # 60-5158-234 with lot # 0310081; Cat. #60-5158-432 with lot #s 0310081, 0310301, 0311101, 0401051, 0401121, 0402031, 0403051, 0411121; Cat. # 60-5158-934 with lot #s 0311101, 0401121.
- 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