FDAMay 15, 2026device
HarmonyAIR A-Series Surgical Lighting System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
What to do
FDA enforcement status: Ongoing
Brands named
steris
UPCs
007249951863880072499518640100724995188320007249951884810072499518846700724995188498007249951894330072499518656200724995188696007249951886270072499518861000724995186074
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHarmonyAIR A-Series Surgical Lighting System2026-05-15
- FDAALYON Surgical Lighting System2026-05-15
- FDAAMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (...2025-11-19
- FDAAMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (...2025-11-19
- FDADual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems2025-06-23
- FDADual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems2025-06-23
- FDABarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H2025-05-23
- FDAHookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to cont...2024-06-13
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