FDA Device recall Z-2484-2018
Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMON…
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMON… by Stryker Sustainability Solutions, citing stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remainin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2484-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-08 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot number 7656512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2484-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.