HARMONIC ACE Shears + Adaptive Tissue Technology — Class II medical device recall Z-2049-2018
Terminated recall by Ethicon Endo-Surgery Inc, reported 2018-06-06, distributed nationwide. The devices may have been assembled with an internal component that may cause continuous or inadvertent activa
| Recall number | Z-2049-2018 |
|---|---|
| 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 | 2018-05-03 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2019-11-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JM, JO, JP, KE, KR, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, PA, PE, PH, PK, PL, PT, RO, RS, RU, SE, SG, SI, SK, TH, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 146,326 |
| UPC / GTIN / UDI-DI | 10705036014447 |
Product
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Reason for recall
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
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-2049-2018. 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.