FDA recall, , Moderate risk
ALYON and HarmonyAIR A-Series Surgical Lighting System
The surgical lighting system has light intensity control buttons that may detach.
Summary by Recall Canary from the FDA notice
What happened
Steris Corporation of Mentor, Ohio is recalling the HarmonyAIR A-Series Surgical Lighting System and the ALYON Surgical Lighting System because the plus and minus buttons used to control light intensity on the light heads may detach. The company began the recall on May 15, 2026, and the FDA added it to its Enforcement Report on June 15, 2026. The products were distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
HarmonyAIR A-Series Surgical Lighting System
- UDI-DI
- 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
ALYON Surgical Lighting System
- UDI-DI
- 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
- 00724995223229
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- Steris CorporationMentor, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98768
- Recall numbers
- Z-2449-2026 to Z-2450-2026
All recalls from Steris Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
