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.

Recall Insight

This FDA Devices action (record #Z-2903-2020) was formally reported on September 2, 2020, with the manufacturer initiating the action on July 21, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Neurovision Medical Products Inc is listed as the recalling firm, operating out of Ventura, CA. Federal records indicate N/A units are affected.

The documented reason for this recall is: 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 E… Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.