Epix Electrosurgical Probes with Smoke Evacuation — Class II medical device recall Z-0509-2020
Terminated recall by Applied Medical Resources Corp, reported 2019-11-27, distributed nationwide. Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
| Recall number | Z-0509-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2018-12-12 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2021-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, ES, FI, FR, GB, IL, IN, IT, LB, NL, PT |
| UPC / GTIN / UDI-DI | 00607915136147, 20607915139050 |
| Lot numbers | 1336418, 1340118, 1340206, 1340803, 1342169, CW002, TA211 |
| Model numbers | 1336418, 1340118, 1340206, 1342169, CW002, TA211 |
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.
Reason for recall
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0509-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.