Stryker Sustainability Solutions: Medical Device Recall in 2021 - (Recall #: Z-1327-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 19, 2021

Date Posted: April 7, 2021

Recall Number: Z-1327-2021

Event ID: 87434

Reason for Recall:

Product was distributed without receiving regulatory clearance.

Status: Ongoing

Product Quantity: 102 units

Code Information:

Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.

Voluntary or Mandated:

Voluntary: Firm initiated