Quick summary
Quick summary: HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System. Reason: Health product recall. Category: Health products. Date: 2026-05-21.
Public recall detail
HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System
2026-05-21
Health products
Health product recall
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System. Reason: Health product recall. Category: Health products. Date: 2026-05-21.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandSteris Corporation
ProductHarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82097
Affected products
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model0000002L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00003A2V
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00003A2L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model003A2A1L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00003A2LT
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00003L2V
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model004A3L2V
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model004A3L2VT
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00003L2L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model004A3L2L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductAlyon Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model1955038X
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlyon Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model13A11L09F
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00013A11F
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model11041370
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00000011L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00011L09F
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model00011L09L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
ProductHarmonyair A-Series Surgical Lighting System
LotMore than 10 numbers, contact manufacturer.
Model13V11L09L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmonyair A-Series Surgical Lighting System
Issue
Steris identified through customer complaints that on Harmonyair A-Series Lighting System and Alyon Surgical Lighting System the plus/minus (+/-) buttons that control light intensity on the light heads may detach. If detachment occurs during a patient procedure, the buttons could enter the sterile field and disrupt the procedure resulting in a procedure delay. 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 manual. Should detachment of the plus/minus (+/-) buttons occur prior to the correction being completed, users should immediately contact their local Steris representative.
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesSteris Corporation 2720 Gunter Park East, Montgomery, Alabama, United States, 36109
Recall date2026-04-14
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82097
Background{}
CompaniesSteris Corporation 2720 Gunter Park East, Montgomery, Alabama, United States, 36109
AudiencesHealthcare
Source updated2026-05-21
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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