Sterile Handpiece Sheaths — Class II medical device recall Z-1758-2017
Terminated recall by ConMed Corporation, reported 2017-04-19, distributed nationwide. For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manuf
| Recall number | Z-1758-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2017-02-28 |
| Classified | 2017-04-07 |
| Reported by FDA | 2017-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, GB, IE, IT |
| Reason classes | labeling, sterility |
| Serial numbers | 15320037, 15330049, 15330052, 15330053, 15340074, 15350086, 15360096, 15360105, 15360108, 154000269, 15400254, 15400255, 15400256, 15400257, 15400258, 15400259, 15400260, 15400261, 15400262, 15400263, 15400264, 15400265, 15400266, 15400267, 15400268 and 368 more |
| Model numbers | 7-900-220 |
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---
Reason for recall
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.