FDA Medical Device Recalls (openFDA)
Conmed Corporation: 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York
- Recall number
- Z-1184-03
- Recalling firm
- Conmed Corporation
- Product
- 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York
- Status
- Terminated
- Initiated
- 2003-07-30
- Posted
- 2003-08-27
- Terminated
- 2005-03-21
- Reason
- Separation of the sensing element from the body of the electrode.
- Root cause
- Other
- Action
- Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.
- Quantity
- 200,412 electrodes (# corrected 9/5/03)
- Distribution
- 241 direct accounts including wholesalers and medical facilities. Of these, there are 15 foreign consignees in Canada, Belgium, Germany, Norway, The Netherlands, Spain, United Kingdom, Japan, Malaysia, Thailand, and United Arab Emirates .
- Lot, serial or model codes
- Cat No. 1680-001: 0305301, 0306091, 0306092. Cat No. 1680-003: 0306241. Cat No. 1680-005: 0306042. Cat No. 1680-030: 0306021, 0306051.
- 510(k) numbers
- ["K991105"]
- PMA numbers
- not on file
- Product code
- DRX
- 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