The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0509-2020·Announced 2019-11-27

Applied Medical Recalls Epix Electrosurgical Probes Due to Tip Insulation Shifting

Applied Medical Resources Corp is recalling Epix Electrosurgical Probes because the tip insulation may shift unintentionally. The recall affects 28 units in the US and 112 units internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect in a medical device used during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Applied Medical Resources Corp is recalling Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm (REF CW002). The recall is due to a defect where the tip insulation of the probes may shift unintentionally. These devices are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures.

The recall includes 28 units distributed domestically in the United States and 112 units distributed internationally. The affected products were distributed in the US and in Belgium, Germany, Switzerland, Spain, Finland, France, Great Britain, Israel, India, Italy, Lebanon, the Netherlands, and Portugal. The specific lot numbers involved are 1336418 and 1340803, though the UDI codes provided in the source text also reference lot numbers 1340206, 1340118, and 1342169 for model TA211.

Healthcare providers and facilities should stop using the affected electrosurgical probes immediately. Users should contact Applied Medical Resources Corp for instructions on returning the devices or obtaining replacements. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

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…
Manufacturer
Applied Medical Resources Corp
Category
Medical Device — Surgical Instruments
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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