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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86102

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 21, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Neurovision Medical Products Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - 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.

Z-2900-2020
Recall number
Z-2900-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
1,089

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Lots 070919A 072619A, 073119A 082019B, 120219D 120319G 120519A 121819E 121919E 122019B 010820D 011520A 011620A 012320D 012420B 030620A 031220E 052120B 062620A 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.

device · product 2 of 9

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.

Z-2901-2020
Recall number
Z-2901-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
7,250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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

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.

device · product 3 of 9

Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - 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.

Z-2902-2020
Recall number
Z-2902-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
1,239

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Lots: 012320C 012720C 012820B 012920C 013020C 020720D 021020D 021320E 021420B 021420D 021820B 031220A 031620C 041620A 052120C 060820F 061120B 111319C 120219G 120619A 121819B 121919F 122319B 122719A 123019A 072919B 073019A 073119B 010820E 090419A 112619A 101019B 102319B 102819A 102919A 103019A 103119A 111219F 112619G 112719C 120219F 060420A 062920A

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.

device · product 4 of 9

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.

Z-2903-2020
Recall number
Z-2903-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 5 of 9

Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - 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.

Z-2904-2020
Recall number
Z-2904-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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 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 112719G 112719H 120219B 120319B 120619C 051220A 051920A 052620A 052820C 060120C 061120A 061220B

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.

device · product 6 of 9

Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - 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.

Z-2905-2020
Recall number
Z-2905-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Lots: 012320C 012720C 012820B 012920C 013020C 020720D 021020D 021320E 021420B 021420D 021820B 031220A 031620C 041620A 052120C 060820F 061120B 072919B 073019A 073119B 010820E 090419A 112619A

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.

device · product 7 of 9

Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - 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.

Z-2906-2020
Recall number
Z-2906-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
1,005

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Lots: 022119A 050219A 051419A 060519A 062119B 081919B 082019C 082619B 082719C 061720B 061720D 120919D

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.

device · product 8 of 9

Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - 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.

Z-2907-2020
Recall number
Z-2907-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
3,425

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Lots: 021919D 022019B 040119C 040319C 040419A 071019A 010820C 020520C 021020I 021220A 061220A 061720C 120419E 120919B 042319A 072419B 091019A 091619A 091719C 092019A 092419A 050219B 051419B 052819A 060519B 070519A 022019B 022619C 061319B 061419B 072619B 061820C 080919A 081419C 082219A 082619C 052120A 110719A 111919A 121319A 022020B 022420A 031720C 062420C 041020A

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.

device · product 9 of 9

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.

Z-2908-2020
Recall number
Z-2908-2020
Initiated
July 21, 2020
Classification
Class II
Status
Terminated
Quantity
1,058

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.