Class IV New Era medical laser device — Class II medical device recall Z-0440-2021
Ongoing recall by Inova Lasers LLC, reported 2020-11-25, distributed nationwide. The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC)
| Recall number | Z-0440-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Inova Lasers LLC, New York, NY, United States |
| Recall initiated | 2020-01-29 |
| Classified | 2020-11-17 |
| Reported by FDA | 2020-11-25 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
Product
Class IV New Era medical laser device
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0440-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.