Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Ster...

FDA Device Recall #Z-2901-2020 — Class II — July 21, 2020

Recall Summary

Recall Number Z-2901-2020
Classification Class II — Moderate risk
Date Initiated July 21, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Neurovision Medical Products Inc
Location Ventura, CA
Product Type Devices
Quantity 7,250

Product Description

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.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, SC, SD, TN, TX, WA, WI and the countries of Canada, Dominican Republic, Hong Kong.

Lot / Code Information

Kit Lots 052219E 052219D 052319A 052919C 053119C 060319A 060619A 060719C 061119A 061419A 061919A 062119A 070119C 071219B 080819B 082719E 091219A 091219B 091319A 091619C 091619D 102519A 110719E 110819B 111219A 111519A 111819B 111919E 112019B 112619C 012920A 020420D 020520B 020620A 020620D 020620G 021020E 021420A 021720D 022020C 022420E 030920C 030920D 031620A 031620B 041620B 051920C 060820E 071719A 071819D 072519A 072519C 080819C 081319A 081919A 082619E 091819B 091919A 091919F 100119A 101019A 101019C 101419D 101719A 110519A 110519B 110519C 110719F 012220A 012220E 012320B 012420D 012820A 012820C 042419A 042519B 042519A 050319A 050619A 050719A 051419C 052119B 082619D 042419A 042519B 042519A 050319A 050619A 050719A 051419C 052119B 082619D 112719G 112719H 120219B 120319B 120619C 051220A 051920A 052620A 052820C 060120C 061120A 061220B 062620B

Other Recalls from Neurovision Medical Products Inc

Recall # Classification Product Date
Z-2100-2025 Class II Brand Name: Hummingbird Product Name: Stimulat... May 19, 2025
Z-2719-2024 Class II Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003... Jul 1, 2024
Z-2902-2020 Class II Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch ... Jul 21, 2020
Z-2907-2020 Class II Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DC... Jul 21, 2020
Z-2903-2020 Class II Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S... Jul 21, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Neurovision Medical Pr... Recalls by Firm Recall Reasons Device Safety Stats