Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
- Company
- Stryker Communications
- Recall Initiated
- July 15, 2025
- Posted
- September 24, 2025
- Recall Number
- Z-2620-2025
- Quantity
- 40
- Firm Location
- Flower Mound, TX
Reason for Recall
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Distribution
US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
Lot / Code Info
UDI-DI: 07613327296167 and 07613327651317 REF/Serial Numbers: CH00000001/7000010116, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010141, 7000010142, 7000010177, 7000010178, 7000010148, 7000010149, 7000010157, 7000010137, 7000010175, 7000010176, 7000010145, 7000010146, 7000010147, 7000010309, 7000010305, 7000010307, 7000010296, 7000010143, 7000010150, 7000010151, 7000010155. P60034/1000022, 1000023, 1000024, 1000016, 1000017, 1000018, 1000019, 1000020, 1000021
Root Cause
Component change control
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.