Neuro Kinetics — Class II medical device recall Z-2730-2015
Terminated recall by Neuro Kinetics, Inc., reported 2015-09-09, distributed nationwide. The devices that included the OVAR research test were not cleared for marketing and mTBI research package was
| Recall number | Z-2730-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neuro Kinetics, Inc., Pittsburgh, PA, United States |
| Recall initiated | 2015-07-21 |
| Classified | 2015-09-03 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 45 |
| Reason classes | labeling, unapproved product |
Product
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
Reason for recall
The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
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-2730-2015. 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.