FDA Device recall Z-0728-2013
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cu…
- FDA Device
- Class II
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class II recall of Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cu… by Conmed, citing conMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0728-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-27 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Conmed |
| Distribution | US |
Product
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Reason
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
Identifiers
| code_info | Beginning Lot Code 120628X, Ending Lot Code 120725X. [Lot codes on boxes and packaging contain a lot code in the follo…Beginning Lot Code 120628X, Ending Lot Code 120725X. [Lot codes on boxes and packaging contain a lot code in the following form: 120725X where 12 represents the year (2012), 07 represents the month (July), 25 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-0728-2013%22
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