Recall Z-2620-2025 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
| Date | Sep 24, 2025 (initiated Jul 15, 2025) |
| Status | Open, Classified |
| Reason | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. |
| Root cause | Component change control |
| 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 repres |
| Quantity | 40 |
| Distribution | US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.