FDA Enforcement
Class II
Ongoing
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Recall: Z-1688-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1688-2026
- Event ID
- 98514
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Communications
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- April 8, 2026
- Initiation Date
- February 23, 2026
- Classification Date
- March 27, 2026
- Address
- 571 Silveron Blvd, Flower Mound, TX, 75028, United States
Description
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Reason
Surgical light assembly may not adequate support the weight of the ceiling cover.
Code Info
UDI: 07613327296167; All Lots
Distribution
Worldwide - US Nationwide distribution.
Quantity
6170 units