Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Box Label: 3 mm Cueva Electrode Kit Recalled by Ad-Tech Medical Instrument Corporation Due to The recall has been initiated due to concerns...

Date: October 8, 2014
Company: Ad-Tech Medical Instrument Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ad-Tech Medical Instrument Corporation directly.

Affected Products

Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.

Quantity: 13 kits (26 electrodes, 26 applicator wands, 26 leadwires).

Why Was This Recalled?

The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ad-Tech Medical Instrument Corporation

Ad-Tech Medical Instrument Corporation has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report