FDA Device recall Z-2049-2018

HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 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 / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 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-2049-2018
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 / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 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	N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K,… N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V,

code_info

N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K,…

N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V,

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-2049-2018%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.