CLASS II ONGOING Device recall · Reported 25 Nov 2020 · FDA Enforcement Report
Class IV New Era medical laser device recalled by Inova Lasers
Inova Lasers is recalling Class IV New Era medical laser device, distributed nationwide in the US. The recall was initiated on 29 Jan 2020 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-0440-2021
- FDA event ID
- 86706
- Recalling firm
- Inova Lasers, New York, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Jan 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +293 days |
| 25 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Product as listed by the FDA
Class IV New Era medical laser device
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Which lots are affected?
New Era laser units
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.
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