CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Cobra, 3-Plate EMG ET Tube recalled by Neurovision Medical Products
Neurovision Medical Products is recalling Cobra, 3-Plate EMG ET Tube, distributed nationwide in the US. The recall was initiated on 1 Jul 2024 and the FDA has classified it as Class II.
Check your package
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-2719-2024
- FDA event ID
- 94931
- Recalling firm
- Neurovision Medical Products, Ventura, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jul 2024
- FDA classified
- 23 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2024 | Recall initiated by company | |
| 23 Aug 2024 | Classified by FDA | +53 days |
| 4 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Product as listed by the FDA
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Which lots are affected?
LOT: 051724B/ UDI: B006LTE7003PS52
Where was it sold?
US Nationwide distribution.
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.
More recalls from Neurovision Medical Products
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stimulated EMG Kit with Hummingbird recalled | Neurovision Medical Products | Packaging Defects | CA |
| Device | CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide |
| Device | CLASS II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recalled | Neurovision Medical Products | Other | Nationwide |
| Device | CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide |
| Device | CLASS II | Cobra x5 1-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide |
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