FDA Device recall Z-1327-2021
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc
- FDA Device
- Class II
- ongoing
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc by Stryker Sustainability Solutions, citing product was distributed without receiving regulatory clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1327-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-01-19 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
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
Product was distributed without receiving regulatory clearance.
Identifiers
| code_info | Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2021%22
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