The FDA has posted 7 enforcement recalls of ceiling mounted surgical light devices since 2025, none of them Class I (most serious). Most recent report: Jun 24, 2026.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Surgical light assembly may not adequate support the weight of the ceiling cover.
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within…
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Light, Surgical, Ceiling Mounted”). Informational only — verify against the FDA before acting.