Harmonyair A-Series Surgical Lighting System Recall
Summary
Health Canada has issued a Type II recall for the Harmonyair A-Series Surgical Lighting System, manufactured by Steris Corporation, due to two separate defects: paint from the light head may peel or chip over time during routine cleaning procedures, and the plus/minus (+/-) buttons controlling light intensity may detach on a smaller subset of units. Paint particles or detached buttons entering the sterile field during a procedure could cause delays and/or present a risk of patient infection. Twelve model/catalogue numbers are affected, including 00013A11LT, 00013A11L, 13A11L09F, 11008835, 00013A11F, 11041370, 00000011L, 00013H11L, 00011L09F, 13A11L09L, 00011L09L, and 13V11L09L. Healthcare facilities with these devices are advised to contact the manufacturer for further information.
“Steris identified through customer complaints that paint from the lighting system's light head may begin to peel or chip over time as a result of routine cleaning procedures.”
About this source
Health Canada operates a single recalls and safety alerts portal covering food, drugs, medical devices, consumer products, vehicles, and cosmetics. Roughly 100 alerts a month, with each entry tagged by hazard type, affected lots, distributor, and recommended consumer action. The portal is bilingual and aligns closely with FDA recalls in scope, so a Health Canada alert often signals a US recall is coming or has just landed. Watch this if you sell into Canada, run cross-border product compliance, or trade pharma equities exposed to recall events. Recent examples: Stryker Variax 2 locking screws pulled non-sterile, a Baxter head positioning adapter Type I recall, an Alecensaro hypertriglyceridemia and pancreatitis safety signal.
What changed
Health Canada issued a Type II recall for the Harmonyair A-Series Surgical Lighting System after Steris Corporation identified that paint from the light head may peel or chip during routine cleaning, and that +/- buttons controlling light intensity may detach on certain units. Paint or button fragments entering the sterile field during a procedure could cause delays and present infection risk to patients. No adverse events during actual use have been reported to date. Healthcare facilities with these devices should contact Steris Corporation directly for inspection, replacement, or remediation options. This recall affects multiple model/catalogue numbers and lot quantities, with identification number RA-81917.
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Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Harmonyair A-Series Surgical Lighting System
Brand(s)
Last updated
2026-04-23
Summary
Product Harmonyair A-Series Surgical Lighting System Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013A11LT |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013A11L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 13A11L09F |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 11008835 |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013A11F |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 11041370 |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00000011L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013H11L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00011L09F |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 13A11L09L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00011L09L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 13V11L09L |
Issue
Steris identified through customer complaints that paint from the lighting system's light head may begin to peel or chip over time as a result of routine cleaning procedures. While Steris has not received any reports of paint falling from a lighting system during use, if paint particles were to enter the sterile field or fall onto a patient, this could disrupt the procedure resulting in a procedure delay and/or may present a risk of patient infection.
Separately, on a smaller number of lighting systems, 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.
Additional information
Details
Original published date:
2026-04-23
Alert / recall type Health product recall Category Health products - Medical devices - General and plastic surgery Companies Steris Corporation
2720 Gunter Park East, Montgomery, Alabama, United States, 36109
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-04-14
Identification number RA-81917
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