Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
FDA device recall Z-1688-2026 · posted 2026-03-27 · Open, Classified
Recall details
- Recalling firm
- Stryker Communications
- Reason for recall
- Surgical light assembly may not adequate support the weight of the ceiling cover.
- Action taken
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Open, Classified
- Product code
- FSY
- Quantity affected
- 6170 units
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2026-02-23
- Date posted
- 2026-03-27
- Location
- Flower Mound, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHROMOPHARE F 628 AND F 528 (K120392) | Berchtold GmbH & Co. KG | 2012-02-16 |