Z-2449-2026Class II

HarmonyAIR A-Series Surgical Lighting System

Name: Z-2449-2026 HarmonyAIR A-Series Surgical Lighting System
Creator: Steris Corporation
Published: 2026-05-15
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2026-05-15 / Open, Classified / root cause: manufacturing process

FDA source

Steris Corporation began a recall of HarmonyAIR A-Series Surgical Lighting System on 2026-05-15. FDA classified it as Class II and gives the reason as "The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2449-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-15
Posted: 2026-06-15
Recalling firm: STERIS Corporation
Product: HarmonyAIR A-Series Surgical Lighting System
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 5/1/26 was sent to customers. STERIS Action All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible. For the paint issue, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced. For the button issue, each affected lighting system will undergo inspection for any signs of potential separation from the light head and handle. Buttons failing this inspection will be replaced. User Action Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the Operator Manuals. Should any issues be observed prior to the correction being completed, users should submit a complaint by contacting STERIS Customer Service at 1-800-548-4873. Users are also reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local Account Manager.
Quantity in commerce: 2101 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2449-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2449-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-15
Z-2450-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-15

Product code FSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)