Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-2620-2025 · Posted 2025-09-24

Recall StatusOpen, Classified
Product CodeFSY
Date Initiated2025-07-15
Product Quantity40

Reason for Recall

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

Firm Action

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 [email protected] 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.

Root Cause

Component change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑