HARMONICHD 1000i Shears — Class II medical device recall Z-2356-2021
Ongoing recall by Ethicon Endo-Surgery Inc, reported 2021-09-01, distributed nationwide. An internal component may be cracked and become lodged behind the energy button potentially resulting in conti
| Recall number | Z-2356-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2021-07-20 |
| Classified | 2021-08-26 |
| Reported by FDA | 2021-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GR, HK, HR, IE, IL, IT, JO, JP, KR, LB, LU, LV, MX, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, TR, TW |
| Quantity | 68,960 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10705036015055 |
| Lot numbers | U94Y9V, U94Y9W, U94Z49, U94Z98, U9503G, U9507E, U95127, U9512D, U9516E, U9518D, U9521Z, U9523L, U9530P, U9530X, U95366, U95427, U9543R, U9548R, U95524, U95525, U95526, U9554U, U95566, U95599, U9564G, U9569W, U9571P, U95754, U95814, U95815, U95856, U9587D, U95A9X, U95C2A, U95D4T, U95E1U, U95E29, U95E6F, U95E72, U95F07 and 11 more |
Product
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Reason for recall
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
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-2356-2021. 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.