Class IV New Era medical laser device recall
Class IV New Era medical laser device
Why was Class IV New Era medical laser device 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
New Era laser units
- Product
- Class IV New Era medical laser device
- Recalling firm
- Inova Lasers LLC
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution
- Recall date
- November 25, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)