# FDA recall Z-0440-2021

> **Inova Lasers LLC** · Class II · device recall initiated 2020-01-29.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0440-2021
- **Recalling firm:** Inova Lasers LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-01-29
- **Report date:** 2020-11-25

- **Voluntary/Mandated:** FDA Mandated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2021

## Citation

> AI Analytics. FDA recall Z-0440-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0440-2021. Source: US FDA. Licensed CC0.

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