FDA Enforcement
Class II
Ongoing
ALYON Surgical Lighting System
Recall: Z-2450-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2450-2026
- Event ID
- 98768
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Steris Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 24, 2026
- Initiation Date
- May 15, 2026
- Classification Date
- June 15, 2026
- Address
- 5960 Heisley Rd, Mentor, OH, 44060-1834, United States
Description
ALYON Surgical Lighting System
Reason
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Code Info
UDIs: 00724995223182 00724995223137, 00724995223151, 00724995223175, 00724995222895, 00724995222994 00724995223014, 00724995223021, 00724995223083, 00724995223106, 00724995222758 00724995223120, 00724995223113, 00724995222840, 00724995223038, 00724995223076 00724995222987, 00724995223007, 00724995222703, 00724995222727, 00724995223090 00724995225711, 00724995225681, 00724995225698, 00724995225728, 00724995222826 00724995222802, 00724995222857, 00724995222697, 00724995222956, and 00724995223229
Distribution
Worldwide - US Nationwide distribution.
Quantity
549 units