HYFRECATOR 2000 HANDPIECE SHEATH — Class II medical device recall Z-1760-2017
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-1760-2017 |
|---|---|
| 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 |
| Lot numbers | 201511234, 201512074, 201512094, 201601064, 201603284 |
| Model numbers | 7-796-19 |
Product
HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.
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-1760-2017. 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.