FDA Device recall Z-2048-2018
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usag…
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usag… by Ethicon Endo Surgery, citing the devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2048-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-03 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 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.
Reason
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Identifiers
| code_info | P9125C, P93T5J, P93T5K, P93V06, P93W4Y, P93Y4A, P93W8A, P9400F, P9409V, P94A93, P94A94, P94C8R,…P9125C, P93T5J, P93T5K, P93V06, P93W4Y, P93Y4A, P93W8A, P9400F, P9409V, P94A93, P94A94, P94C8R, P94G1W, P91F4A, P91F86, P93M3W, P93W0A, P93Z4X, P93Z96, P94E6U, P94H32, P94H9V, P94J28 |
|---|
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-2048-2018%22
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