FDA Device recall Z-0440-2021
Class IV New Era medical laser device
- FDA Device
- Class II
- ongoing
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of Class IV New Era medical laser device by Inova Lasers, citing the firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0440-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-01-29 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Inova Lasers |
| Distribution | US |
Product
Class IV New Era medical laser device
Reason
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.
Identifiers
| code_info | New Era laser units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0440-2021%22
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