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Z-2484-2018 Class II Terminated

Recalled by Stryker Sustainability Solutions — Tempe, AZ

FDA device recall Z-2484-2018 was initiated by Stryker Sustainability Solutions on May 8, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 29, 2019). Affected quantity: 180 units.

Recall Details

Product Type: Devices
Report Date: Jul 25, 2018
Initiation Date: May 8, 2018
Termination Date: Jul 29, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product 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

Code Information

Lot number 7656512

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2484-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.