Sterile Handpiece Sheaths — Class II medical device recall Z-1757-2017
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-1757-2017 |
|---|---|
| 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 | 13181360, 15010013, 15070434, 15221592, 15221593, 15221594, 15221595, 15221596, 15221597, 15221598, 15221599, 15221600, 15240221, 15250297, 15300642, 15300651, 15320844, 15320846, 15320849, 15330856, 15330860, 15330866, 15330905, 15330909, 15340913 and 475 more |
| Model numbers | 7-900-115 |
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.
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.