Box Label: 3 mm Cueva Electrode Kit — Class II medical device recall Z-0106-2015

Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2014-10-29, distributed nationwide. The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the

Recall number	`Z-0106-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ad-Tech Medical Instrument Corporation, Racine, WI, United States
Recall initiated	2014-10-08
Classified	2014-10-21
Reported by FDA	2014-10-29
Terminated	2015-04-08
Distributed	Nationwide (US)
Countries outside the US	FI
Reason classes	device malfunction
Lot numbers	`0060002`, `0061723`, `0067938`, `208140447`, `208140458`, `208140487R`
Model numbers	`CNE1-2KDINX`, `CNE1-3KDINX`

Product

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.

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. .

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-0106-2015. 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.