| Date Initiated by Firm | February 23, 2026 |
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| Date Posted | March 27, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1688-2026 |
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| Recall Event ID |
98514 |
| 510(K)Number | K120392 |
|---|
| Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
| Product | Stryker CHROMOPHARE Softlit Ring Surgical Light System
REF: CH00000001 |
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| Code Information |
UDI: 07613327296167; All Lots |
| FEI Number |
3002975342
|
Recalling Firm/
Manufacturer |
Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
|
| For Additional Information Contact | Stryker Customer Care
1800-624-4422 Ext. 1 |
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Manufacturer Reason
for Recall | Surgical light assembly may not adequate support the weight of the ceiling cover. |
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FDA Determined
Cause 2 | Unknown/Undetermined by 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 CommunicationsRA1@stryker.com. 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.
|
|---|
| Quantity in Commerce | 6170 units |
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| Distribution | Worldwide - US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FSY
|
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