Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
FDA Recall Z-2620-2025 · Posted 2025-09-24
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Recalling FirmStryker Communications
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.
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