Recall Z-1688-2026 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
| Date | Mar 27, 2026 (initiated Feb 23, 2026) |
| Status | Open, Classified |
| Reason | Surgical light assembly may not adequate support the weight of the ceiling cover. |
| Root cause | 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 |
| Quantity | 6170 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120392 | CHROMOPHARE F 628 AND F 528 Berchtold GmbH & Co. KG, Feb 16, 2012 |