Recall Z-2620-2025— Stryker Communications

Class II · Ongoing

Class II FDA medical device recall by Stryker Communications, initiated 2025-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034. Reason: Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur..

Recalling firm
Stryker Communications
Classification
Class II
Status
Ongoing
Initiated
2025-07-15
Firm location
Flower Mound, TX, United States

Product description

Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

Reason for recall

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

Data sourced from openFDA. This site is unofficial and independent of the FDA.