CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report
Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip recalled
Applied Medical Resources is recalling Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, distributed nationwide in the US. The recall was initiated on 12 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0509-2020
- FDA event ID
- 83909
- Recalling firm
- Applied Medical Resources, Rancho Santa Margarita, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2018
- FDA classified
- 21 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 12 Dec 2018 | Recall initiated by company | |
| 21 Nov 2019 | Classified by FDA | +344 days |
| 27 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Questions about this recall
Is Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip recalled?
Yes. Applied Medical Resources recalled Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip on 12 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0509-2020.
Why was it recalled?
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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