Neurovision Medical Products Inc: Medical Device Recall in 2020 - (Recall #: Z-2903-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - 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.

Product Classification:

Class II

Date Initiated: July 21, 2020

Date Posted: September 2, 2020

Recall Number: Z-2903-2020

Event ID: 86102

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Kit Lots: 073119A 082019B 022820A 041620C 062520A

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.

Voluntary or Mandated:

Voluntary: Firm initiated