Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HARMONIC ACE Shears + Adaptive Tissue Technology Recalled by Ethicon Endo-Surgery Inc Due to The devices may have been assembled with an...

Date: May 3, 2018
Company: Ethicon Endo-Surgery Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon Endo-Surgery Inc directly.

Affected Products

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.

Quantity: 146,326

Why Was This Recalled?

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc has 54 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report