FDA DevicesClass II
ALYON Surgical Lighting System
Published: June 24, 2026Recall ID: Z-2450-2026Category: devicesCountry: US
Reason for Recall / Hazard
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Product Description & Identification
ALYON Surgical Lighting System
Additional Source Details
| Field | Value |
|---|---|
| City | Mentor |
| State | OH |
| Event id | 98768 |
| Address 1 | 5960 Heisley Rd |
| 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 |
| Postal code | 44060-1834 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 549 units |
| Reason for recall | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260515 |
| Initial firm notification | Letter |
| Center classification date | 20260615 |
Overview
- Recalling FirmSteris Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.