Stryker Communications recalls Chromophare Surgical Light System

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

On 7/15/2025, recall notices were mailed or hand delivered to customers who were asked to do the following: Inform individuals within your organization who need to be aware of this action. 2. A Stryker representative will be in contact with your account to schedule a field service visit at your earliest convenience to complete the following: a. Deinstall impacted Oculan light(s) and reinstall with SLX lights to ensure your operating room stays in use. b. Upon product remediation and availability, Stryker will return to reinstall Oculan within your operating room(s). Your local Stryker representative will provide timing updates as they are available. 3. Complete and return the Business Reply Form to CommunicationsRA1@stryker.com 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.

• FDA enforcement recordOfficial FDA database entry for Z-2620-2025
• FDA device classification · FSYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4580The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker CommunicationsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.