Inova Lasers LLC: Medical Device Recall in 2020 - (Recall #: Z-0440-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Class IV New Era medical laser device

Product Classification:

Class II

Date Initiated: January 29, 2020

Date Posted: November 25, 2020

Recall Number: Z-0440-2021

Event ID: 86706

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.

Status: Ongoing

Product Quantity: 8 units

Code Information:

New Era laser units

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated