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

FDA device recall Z-2620-2025 · posted 2025-09-24 · Open, Classified

Recall details

Recalling firm

Stryker Communications

Reason for recall

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

Action taken

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.

Root cause

Component change control

Status

Open, Classified

Product code

FSY

Quantity affected

40

Distribution

US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.

Date initiated

2025-07-15

Date posted

2025-09-24

Location

Flower Mound, TX