FDA Medical devices recall ·

Bodor P and C series laser cutting machines recall

Recall number
Z-0768-2025
Date
(initiated December 19, 2024)
Company / brand
Jinan Bodor Cnc Machine Co Ltd
NO.1299, XINLUO AVE HI-TECH ZONE, Jinan, China
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
269 units
Initiated by
FDA Mandated

Read the official FDA notice ↗

Product

Bodor P and C series laser cutting machines

Why was it recalled?

Non-compliant laser products

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

P series is 2421537-000 and C series is 2421612-000.

Distribution

US Nationwide Distribution

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0768-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.