Z-0509-2020Class II

Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 -

Name: Z-0509-2020 Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 -
Creator: Applied Medical Resources Corp
Published: 2018-12-12
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2018-12-12 / Terminated / root cause: design

FDA source

Applied Medical Resources Corp began a recall of 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... on 2018-12-12. FDA classified it as Class II and gives the reason as "Unintentional shifting of the tip insulation of the firm's electrosurgical probes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0509-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-12
Posted: 2019-11-21
Terminated: 2021-01-22
Recalling firm: Applied Medical Resources Corp
Product: 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 code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Root cause tag: design
FDA root cause: Device Design
Action: On12/12/2018, the firm sent an "URGENT; MEDICAL DEVICE RECALL" notification to customers via UPS informing them that this voluntary recall is being conducted due to the possibility that the insulation near the device tip may unintentionally shift. Customers are asked to: Check their inventory for recalled product. Complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if their facility is returning or has already used units or kits from the lots listed. o If no product is being returned, to please indicate that on the Recall Notification Confirmation Form. Provide a no-charge P.O. number if replacement units or kits are requested. If customer is a distributor, they are instructed to notify any facilities to which they distributed units or kits from the affected lots, and to have them complete the appropriate sections of the Recall Notification Confirmation Form. Return the completed Recall Notification Confirmation Form to Applied Medical by emailing it to [email protected] or faxing it to 949-713-8871. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical following the instructions provided. For product return questions, please contact the Manager of Customer Relations, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions, to contact (949) 713-8767 or by email at [email protected].
Quantity in commerce: 28 units Domestically - 112 units Internationally
Distribution: Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0509-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0509-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21
Z-0510-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code GEI

K171684Class IIEpix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources Corporation / cleared 2017-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)