HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis — Class II medical device recall Z-0278-2016
Terminated recall by Ethicon Endo-Surgery Inc, reported 2015-11-25, distributed nationwide. Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
| Recall number | Z-0278-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2015-09-23 |
| Classified | 2015-11-16 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, AW, BE, BR, CA, CL, CN, CO, EC, HK, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, TW, VN |
| Quantity | 441,490 units |
| Reason classes | sterility |
| Lot numbers | 2019-02, 2019-03, 2019-04, 2019-05, 2019-06, 2019-07, 2019-08, 2019-09, 2019-10, 2019-11, 2019-12, 2020-01, 2020-02, 2020-03, 2020-04, 2020-05, 2020-06, 2020-07, 2020-08, L90K2V, L90K2W, L90K2X, L90K4P, L90K4R, L90V6P, L90V8F, L90W33, L90W7K, L90X10, L91023, L9103T, L91080, L9109W, L9110Z, L91144, L9124Z, L9128A, L9131N, L91358, L9138J and 460 more |
| Model numbers | HARH23, HARH36, HARH45 |
Product
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Reason for recall
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
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-0278-2016. 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.