FDA Medical devices recall ·
Bodor's I series laser cutting machine recall
- Recall number
- Z-2149-2025
- Date
- (initiated February 7, 2025)
- Company / brand
- Jinan Bodor Cnc Machine Co Ltd
NO.1299, XINLUO AVE HI-TECH ZONE, Jinan, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Bodor's I series laser cutting machine.
Why was it recalled?
The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
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
The Accession Number is 2421628- 001.
Distribution
US
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-2149-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.