Ad-Tech Medical Instrument Corporation: Medical Device Recall in 2014 - (Recall #: Z-0106-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 8, 2014

Date Posted: October 29, 2014

Recall Number: Z-0106-2015

Event ID: 69436

Reason for Recall:

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

Status: Terminated

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

Code Information:

Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.

Distribution Pattern:

Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.

Voluntary or Mandated:

Voluntary: Firm initiated