Steris HarmonyAIR A-Series Surgical Lights: Buttons May Detach
Steris recalls HarmonyAIR A-Series surgical lighting systems with specific UDIs due to risk of plus/minus buttons detaching during use.
Use caution until it’s fixed
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Contact the company
What happened, in plain English
Steris is recalling HarmonyAIR A-Series surgical lighting systems because the light intensity buttons (+/-) can detach. This could cause the lights to malfunction during surgery, potentially affecting patient safety. Read more at govinfonow.com/recall/49158-steris-harmonyair-a-series-surgical-lights-buttons-may-detach.
Source Summary by GovInfoNow · govinfonow.com/recall/49158-steris-harmonyair-a-series-surgical-lights-buttons-may-detach · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2449-2026
Cite this page
“Steris HarmonyAIR A-Series Surgical Lights: Buttons May Detach.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49158-steris-harmonyair-a-series-surgical-lights-buttons-may-detach. Based on FDA recall #Z-2449-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2449-2026%22&limit=1).
Why it’s dangerous
The plus and minus buttons that control light intensity on the light heads can become detached during use. If the buttons detach, the lighting system may malfunction, which could lead to inadequate surgical lighting conditions.
Who’s affected
Surgical teams using HarmonyAIR A-Series lighting systems with the listed Unique Device Identifiers (UDIs) are most at risk. Hospitals and medical facilities that have these specific models should check their inventory.
How to tell if you have this one
Check the Unique Device Identifier (UDI) on the product label. The affected units have specific UDIs listed in the recall notice, including numbers like 00724995185947 and 00724995186418.
- Brand
Steris- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2449-2026 | HarmonyAIR A-Series Surgical Lighting System; UDIs: 00724995185947, 00724995186418, 00724995187156, 00724995188009, 00724995188498, 00724995189198, 00724995185954, 00724995186425, 00724995187170, 00724995188016 00724995188504, 00724995189211, 00724995185961, 00724995186432, 00724995187187 00724995188047, 00724995188535, 00724995189228, 00724995185978, 00724995186548 00724995187217, 00724995188054, 00724995188542, 00724995189280,00724995185985, 00724995186555, 00724995187248, 00724995188078, 00724995188580, 00724995189372, 00724995186067, 00724995186562, 00724995187262, 00724995188122, 00724995188597, 00724995189419, 00724995186074, 00724995186579, 00724995187279, 00724995188221, 00724995188603, 00724995189990, 00724995186081, 00724995186593, 00724995187286, 00724995188238, 00724995188610, 00724995190002, 00724995186098, 00724995186616, 00724995187347, 00724995188245, 00724995188627, 00724995190033, 00724995186111, 00724995186623, 00724995187378, 00724995188252, 00724995188634, 00724995190040, 00724995186128, 00724995186661, 00724995187385, 00724995188269, 00724995188641, 00724995190354, 00724995186135, 00724995186678, 00724995187415, 00724995188276, 00724995188658, 00724995190361, 00724995186203, 00724995186685, 00724995187453, 00724995188283, 00724995188665, 00724995199364, 00724995186302, 00724995186692, 00724995187484, 00724995188290, 00724995188672, 00724995199913, 00724995186319, 00724995186722, 00724995187538, 00724995188306, 00724995188689, 00724995199944, 00724995186326, 00724995186739, 00724995187569, 00724995188313, 00724995188702, 00724995200480, 00724995186333, 00724995186746, 00724995187576, 00724995188320, 00724995188726, 00724995200886, 00724995186340, 00724995186753, 00724995187583, 00724995188337, 00724995188849, 00724995200909,00724995186357, 00724995186760, 00724995187606, 00724995188344, 00724995188948, 00724995200930, 00724995186364, 00724995186784, 00724995187620, 00724995188375, 00724995189068, 00724995200947, 00724995186371, 00724995186807, 00724995187712, 00724995188412, 00724995189075, 00724995200961, 00724995186388, 00724995186906, 00724995187729, 00724995188467, 00724995189105, 00724995201074, 00724995186395, 00724995187125, 00724995187989, 00724995188474, 00724995189136, 00724995217372, 00724995186401, 00724995187149, 00724995187996, 00724995188481, 00724995189181, 00724995222970 | 2101 units |
| Z-2450-2026 | ALYON Surgical Lighting System; 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 | 549 units |
What to do — step by step
Check Product Label
Look for the Unique Device Identifier (UDI) on the lighting system to confirm if it is affected.
Contact Steris
Reach out to Steris Corporation for guidance on next steps if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2449-2026 (May 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2449-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.