FDA Recall Open, Classified

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Recall: Z-1688-2026 · Initiated February 23, 2026

Recall

Recall Number
Z-1688-2026
Event Number
98514
Firm
Stryker Communications
FEI Number
3002975342
Product Code
FSY
Status
Open, Classified
Root Cause
Unknown/Undetermined by firm
Initiated
February 23, 2026
Posted
March 27, 2026
Address
571 Silveron Blvd, Flower Mound, TX, 75028

Description

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Reason

Surgical light assembly may not adequate support the weight of the ceiling cover.

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.

Distribution

Worldwide - US Nationwide distribution.

Quantity

6170 units