FDA Issues Nationwide Recall of Bodor Laser Machines Over Safety and Compliance Concerns

Date:

The U.S. Food and Drug Administration (FDA) has initiated a Class II recall of Bodor Laser’s P Series and C Series laser cutting machines, citing safety deficiencies and noncompliance with regulatory labeling requirements. This action marks a significant move by federal authorities to strengthen oversight of imported industrial equipment in the United States.

According to the FDA official notice, the recall stems from the discovery that the affected machines were missing essential safety features, including proper interlock systems and presence detection mechanisms — both of which are considered standard for operator protection in industrial environments. These components help prevent unintended operation or access during machine activity, and their absence could lead to elevated safety risks during use.

The FDA recall follows a January 2025 announcement by Bodor, in which the company voluntarily advised all dealers and machine owners to inspect and update specific models for improved compliance. The advisory noted concerns around the protective housing structure and side-door interlocks, encouraging immediate safety reviews and system upgrades.

In February 2025, the situation escalated with an FDA-issued Import Alert, identifying noncompliance with the agency’s requirements for electronic product certification labeling. This alert imposes stricter import controls and may delay or restrict further shipments of the P and C Series laser cutters into the U.S. market.

The recall applies to all affected machines manufactured and distributed between 2018 and 2024. Bodor has outlined a corrective plan that includes:

• Installation of visual collision detection systems

• Integration of access door interlock mechanisms

On-site inspections and hardware retrofits, offered to customers at no additional cost

Industry observers note that the FDA’s actions reflect a growing focus on international product safety compliance, particularly as industrial automation and laser processing systems become more advanced and widespread.

The recall has prompted many U.S. metal fabricators and OEMs to review their installed equipment and confirm certification status, especially in high-volume production settings where operational safety is paramount.

TIME BUSINESS NEWS

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