Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HA...

FDA Device Recall #Z-2484-2018 — Class II — May 8, 2018

Recall Summary

Recall Number Z-2484-2018
Classification Class II — Moderate risk
Date Initiated May 8, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Sustainability Solutions
Location Tempe, AZ
Product Type Devices
Quantity 180 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN

Lot / Code Information

Lot number 7656512

Other Recalls from Stryker Sustainability Solutions

Recall # Classification Product Date
Z-0490-2026 Class II HARMONIC FOCUS Shears + Adaptive Tissue Technol... Sep 24, 2025
Z-2689-2024 Class II Disposable 5 Lead Cable and Lead Wire System, 5... Jul 2, 2024
Z-2405-2024 Class II REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (... May 31, 2024
Z-2268-2024 Class II Stryker Sustainability Solutions, BW Lasso 2515... May 10, 2024
Z-2394-2023 Class II HoverMatt, 39" W x 78" L, REF: HM39SPU-B Jun 21, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.