FDA
Food and Drug Administration · Recall Z-2449-2026 · May 15, 2026HarmonyAIR A-Series Surgical Lighting System
Steris Corporation
The hazard
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
HarmonyAIR A-Series Surgical Lighting System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDIs: 00724995185947Model 00724995186418Model 00724995187156Model 00724995188009Model 00724995188498Model 00724995189198Model 00724995185954Model 00724995186425Model 00724995187170Model 00724995188016 00724995188504Model 00724995189211Model 00724995185961Model 00724995186432Model 00724995187187 00724995188047Model 00724995188535Model 00724995189228Model 00724995185978Model 00724995186548 00724995187217Model 00724995188054Model 00724995188542Model 00724995189280Model 00724995185985Model 00724995186555Model 00724995187248Model 00724995188078UPC 00724995185947UPC 00724995186418UPC 00724995187156UPC 00724995188009UPC 00724995188498UPC 00724995189198UPC 00724995185954UPC 00724995186425UPC 00724995187170UPC 00724995188016UPC 00724995188504UPC 00724995189211UPC 00724995185961UPC 00724995186432UPC 00724995187187UPC 00724995188047UPC 00724995188535UPC 00724995189228UPC 00724995185978UPC 00724995186548UPC 00724995187217UPC 00724995188054UPC 00724995188542UPC 00724995189280UPC 00724995185985Would you have heard about this one?
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