FDA Medical devices recall ·
ALYON Surgical Lighting System recall
- Recall number
- Z-2450-2026
- Date
- (initiated May 15, 2026)
- Company / brand
- Steris Corporation
5960 Heisley Rd, Mentor, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 549 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ALYON Surgical Lighting System
Why was it recalled?
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2450-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.