Summary
The FDA issued a Class II for ALYON Surgical Lighting System by Steris Corporation. Reason: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach..
Details
Source
Device Recall
External ID
Z-2450-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
ALYON Surgical Lighting System
Lot/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
Quantity Affected: 549 units
Reason for Recall
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-15
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2450-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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