Sterile Handpiece Sheaths — Class II medical device recall Z-1756-2017
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-1756-2017 |
|---|---|
| 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 | 15250002, 15250004, 15250005, 15250006, 15250007, 15250008, 15260010, 15260012, 15260013, 15280023, 15280024, 15280026, 15290032, 15290033, 15300038, 15350041, 15350043, 15350044, 15360054, 15360057, 15360059, 15360060, 1540139, 1540144, 15420101 and 41 more |
| Model numbers | 7-900-100 |
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- 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.