FDA Medical Device Recalls (openFDA)
Jinan Bodor Cnc Machine Co Ltd: Bodor's I series laser cutting machine.
- Recall number
- Z-2149-2025
- Recalling firm
- Jinan Bodor Cnc Machine Co Ltd
- Product
- Bodor's I series laser cutting machine.
- Status
- Open, Classified
- Initiated
- 2025-02-07
- Posted
- 2025-07-23
- Terminated
- not on file
- 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).
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Jinan Bodor CNC Machine Co. Ltd., and its subsidiary, Bodor Laser Inc., (collectively and individually, Bodor ) sent letters to customers to inform them the FDA has determined that i Series Products fail to meet certain applicable Federal Standards. The letter also provides Corrective Action Plan and instructions of 'Continued Use of Product While Corrective Actions are Pending'.
- Quantity
- 20
- Distribution
- US
- Lot, serial or model codes
- The Accession Number is 2421628- 001.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFE
- Firm FEI
- 3008620561
- Firm city
- Jinan
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28