July 23, 2025 — With a second FDA-listed recall in 2025, Bodor Laser is under heightened safety scrutiny in the U.S. market; back-to-back Class II actions point to ongoing compliance remediation rather than a one-off issue. July 23, 2025 — The U.S. Food & Drug Administration (FDA) has posted a new Class II device recall involving Bodor’s i-Series laser cutting machines, citing failures to meet applicable federal laser-product standards (21 CFR 1040.10(f)(1) and 1040.10(f)(2)). The action was initiated by the manufacturer on February 7, 2025 and formally posted by FDA on July 23, 2025. According to the filing, 20 units distributed in the United States are affected. The firm notified customers and outlined a corrective-action plan that allows continued use while fixes are pending.
This latest action follows an earlier Class II recall posted on January, 2025 covering Bodor’s P- and C-Series laser cutters. In that case, the company advised U.S. dealers and purchasers that certain machines were non-compliant laser products and may require updates related to protective housing and safety interlocks, including inspections and retrofits to ensure the equipment stops when an operator enters the enclosure or a side door is opened. 269 units were included, with nationwide U.S. distribution.
What customers were told to do
- i-Series (posted July 23, 2025): Bodor Laser Inc. and Jinan Bodor CNC Machine Co., Ltd. sent letters advising customers that the i-Series failed to meet certain federal standards and provided instructions for corrective action and continued safe use pending remediation.
- P/C-Series (posted Jan. 18, 2025): Customers were informed of required updates addressing protective housing and safety interlocks; the company said it would perform inspections/repairs at customer sites and remedy defects at no charge.
Both entries are currently listed by FDA as Class II, Open, Classified, meaning the firm has initiated a correction/removal and FDA has classified the action; the records remain open until all corrections are completed or the recall is terminated.
Editor’s note: FDA recall database records are created when a company initiates a correction or removal and may be updated as FDA review progresses. Readers can consult the FDA’s device-recall database for the most current status.
