Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery — Class II medical device recall Z-1327-2021
Ongoing recall by Stryker Sustainability Solutions, reported 2021-04-07, distributed nationwide. Product was distributed without receiving regulatory clearance.
| Recall number | Z-1327-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-03-31 |
| Reported by FDA | 2021-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL |
| Quantity | 102 units |
| UPC / GTIN / UDI-DI | 07613327346251 |
| Lot numbers | 12444050 |
| Model numbers | HARH36 |
Product
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.
Reason for recall
Product was distributed without receiving regulatory clearance.
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-1327-2021. 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.