Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
FDA Recall Z-1688-2026 · Posted 2026-03-27
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Recalling FirmStryker Communications
Recall StatusOpen, Classified
Product CodeFSY
Date Initiated2026-02-23
Product Quantity6170 units
Reason for Recall
Surgical light assembly may not adequate support the weight of the ceiling cover.
Firm Action
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Worldwide - US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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