Chromophare Surgical Light System, REF: CH00000001 recallZ-2620-2025 · Stryker Communications · initiated Jul 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Communications or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
FDA root cause category: Component change control
What the company is doing
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.
Recall details
- Recall number
- Z-2620-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 15, 2025
- Posted by the FDA
- Sep 24, 2025
- Recalling firm
- Stryker Communications
- Quantity
- 40
- Product code
- FSY
- Distribution
- US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
Product description
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Chromophare CH00000001Berchtold Holding GmbH · DEVICE, MEDICAL EXAMINATION, AC POWERED3 recalls50 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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