CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products

Neurovision Medical Products is recalling Cobra x5 2-Ch EMG ET Tube, distributed nationwide in the US. The recall was initiated on 21 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKit Lots: 022019A 052919B 053119A 080819A 022519D 081319E 082619A 082719B 021220E 022820C 060120A 110819A 111919F 030519A 030819A 091019B

Quantity recalled1,058

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2908-2020
FDA event ID: 86102
Recalling firm: Neurovision Medical Products, Ventura, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Jul 2020
FDA classified: 27 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

21 Jul 2020	Recall initiated by company
27 Aug 2020	Classified by FDA	+37 days
2 Sep 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - 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.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri Mississippi Nebraska

Questions about this recall

Why was it recalled?

Which lots are affected?

Kit Lots: 022019A 052919B 053119A 080819A 022519D 081319E 082619A 082719B 021220E 022820C 060120A 110819A 111919F 030519A 030819A 091019B

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 86102

This product is part of a recall event; the main page for the event is Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2020	CLASS II	Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Cobra x5 1-CH EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Cobra x5 1-Ch EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Cobra x5 1-Ch EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide
2 Sep 2020	CLASS II	Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recalled	Neurovision Medical Products	Other	Nationwide

More recalls from Neurovision Medical Products

All 11

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025Device	CLASS II	Stimulated EMG Kit with Hummingbird recalled	Neurovision Medical Products	Packaging Defects	CA
4 Sep 2024Device	CLASS II	Cobra, 3-Plate EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Labeling Errors	Nationwide
2 Sep 2020Device	CLASS II	Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recalled	Neurovision Medical Products	Other	Nationwide
2 Sep 2020Device	CLASS II	Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide
2 Sep 2020Device	CLASS II	Cobra x5 1-Ch EMG ET Tube recalled by Neurovision Medical Products	Neurovision Medical Products	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

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