Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube — Class II medical device recall Z-2901-2020
Terminated recall by Neurovision Medical Products Inc, reported 2020-09-02, distributed nationwide. The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over
| Recall number | Z-2901-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neurovision Medical Products Inc, Ventura, CA, United States |
| Recall initiated | 2020-07-21 |
| Classified | 2020-08-27 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DO, HK |
| Quantity | 7,250 |
| Lot numbers | 012220A, 012220E, 012320B, 012420D, 012820A, 012820C, 012920A, 020420D, 020520B, 020620A, 020620D, 020620G, 021020E, 021420A, 021720D, 022020C, 022420E, 030920C, 030920D, 031620A, 031620B, 041620B, 042419A, 042519A, 042519B, 050319A, 050619A, 050719A, 051220A, 051419C, 051920A, 051920C, 052119B, 052219D, 052219E, 052319A, 052620A, 052820C, 052919C, 053119C and 56 more |
| Model numbers | NVTKIT-C7-5 |
Product
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.
Reason for recall
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
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-2901-2020. 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.