Class II — Potential Health Hazard

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

Reprocessed HARMONIC Ace¿ +7 Recalled by Stryker Sustainability Solutions Due to Stryker Sustainability Solutions has received an increase in...

Date: May 8, 2018
Company: Stryker Sustainability Solutions
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 Stryker Sustainability Solutions directly.

Affected Products

Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.

Quantity: 180 units

Why Was This Recalled?

Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Sustainability Solutions

Stryker Sustainability Solutions has 38 total recalls tracked by RecallDetector.

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