Applied Medical Resources Corp: Medical Device Recall in 2019 - (Recall #: Z-0509-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

Product Classification:

Class II

Date Initiated: December 12, 2018

Date Posted: November 27, 2019

Recall Number: Z-0509-2020

Event ID: 83909

Reason for Recall:

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

Status: Terminated

Product Quantity: 28 units Domestically - 112 units Internationally

Code Information:

Model Number: CW002 Lot Numbers: 1336418 and 1340803 Model # Lot # UDI Code CW002 1336418 (01)00607915136147(17)210912(30)01(10)1336418 CW002 1340206 (01)00607915136147(17)211029(30)01(10)1340206 TA211 1340118 (01)20607915139050(17)210812(30)01(10)1340118 TA211 1342169 (01)20607915139050(17)210812(30)01(10)1342169

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.

Voluntary or Mandated:

Voluntary: Firm initiated