FDA Device recall Z-0827-2013
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED C…
- FDA Device
- Class II
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class II recall of ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED C… by Conmed, citing some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-28 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Conmed |
| Distribution | US |
Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Reason
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Identifiers
| code_info | Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the follow…Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2013%22
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