Stryker CHROMOPHARE Softlit Ring Surgical Light System recallZ-1688-2026 · Stryker Communications · initiated Feb 23, 2026
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 light assembly may not adequate support the weight of the ceiling cover.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
On February 23, 2026 Stryker issued "Urgent: Medical Device Recall" via E-Mail to affected consignees. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2.Check your internal inventory to locate the product. 3.Please complete, Business Reply Form, as an acknowledgement of this notice and return the completed form via email to [email protected]. Response is required. 4. A representative will contact affected accounts to schedule a field service visit to complete an inspection and replacement of the affected component. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately.
Recall details
- Recall number
- Z-1688-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 23, 2026
- Posted by the FDA
- Mar 27, 2026
- Recalling firm
- Stryker Communications
- Quantity
- 6170 units
- Product code
- FSY
- FDA submissions
- K120392
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Code information (models, lots, serial numbers)
UDI: 07613327296167; All Lots
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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