Recall archive / FDA device enforcement
Chromophare Surgical Light System , REF CH00000001 — FDA record Z-1506-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Chromophare Surgical Light System , REF CH00000001
- Reason
- Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
- Classification
- Class II
- Recalling firm
- Stryker Communications
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1506-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | S/N:03857056/ UDI: 07613327296167 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: None OUS: Chili
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 17, 2024
- Recall initiation date
- Feb 8, 2024
- Center classification date
- Apr 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.