FDA Medical devices recall ·
HarmonyAIR A-Series Surgical Lighting System recall
- Recall number
- Z-2448-2026
- 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
- 4138 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HarmonyAIR A-Series Surgical Lighting System
Why was it recalled?
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
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: 00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562, 00724995188696, 00724995188627, 00724995188610, 00724995186074, 00724995186081, 00724995186302, 00724995186319, 00724995188269, 00724995186371, 00724995188634, 00724995186326, 00724995186067, 00724995186548, 00724995186579, 00724995188580, 00724995187149, 00724995187170, 00724995187989, 00724995187644, 00724995188337, 00724995189297, 00724995188313, 00724995186128, 00724995188689, 00724995188252, 00724995188474, 00724995188597, 00724995188221, 00724995189174, 00724995188276, 00724995186180, 00724995189143 00724995186111, 00724995186340, 00724995187224, 00724995189075, 00724995188306 00724995188603, 00724995189051, 00724995200954, 00724995200022, 00724995199906 00724995190033, 00724995186678, 00724995188351, 00724995188665, 00724995187996 00724995189068, 00724995189099, 00724995189150, 00724995199869, 00724995187385 00724995187347, 00724995200886, 00724995190361, 00724995200893, 00724995200916 00724995186333, 00724995187026, 00724995187262, 00724995186715, 00724995186746 00724995188283, 00724995187279, 00724995186135, 00724995188511, 00724995188009, 00724995188245, 00724995189310, 00724995186555, 00724995188504, 00724995187033 00724995190354, 00724995188238, 00724995186739, 00724995188290, 00724995199890, 00724995187156, 00724995187187, 00724995187521, 00724995187552, 00724995186142, 00724995186647, 00724995185985, 00724995186104, 00724995187781
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
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-2448-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.