Sterile Handpiece Sheaths — Class II medical device recall Z-1759-2017
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-1759-2017 |
|---|---|
| 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 | 15260015, 15260016, 15260018, 15260020, 15260022, 15260023, 15280038, 15280044, 15280046, 15280048, 15280049, 15280052, 15280053, 15280054, 15280055, 15280056, 15280060, 15280061, 15280062, 15280063, 15330199, 15330200, 15330201, 15330202, 15330203 and 475 more |
| Model numbers | 7-900-230 |
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1759-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.