Summary
The FDA issued a Class II for Bodor's I series laser cutting machine. by Jinan Bodor Cnc Machine Co Ltd. Reason: 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)..
Details
Source
Device Recall
External ID
Z-2149-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
Bodor's I series laser cutting machine.
Lot/Code Info: The Accession Number is 2421628- 001.
Quantity Affected: 20
Reason for Recall
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).
Distribution
US
Type: FDA Mandated
Recall Initiated: 2025-02-07
Company
Jinan, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Jinan Bodor Cnc Machine Co Ltd has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jinan Bodor Cnc Machine Co Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jinan Bodor Cnc Machine Co Ltd have FDA actions?
Jinan Bodor Cnc Machine Co Ltd has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2149-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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