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Harmonyair a-series surgical lighting system

Official notice

12 May 2026

MediumHealth Canada

An official Health Canada notice concerns Harmonyair a-series surgical lighting system. 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. Published 2026-05-12.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81917

Official notice

2026-05-12

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

00013A11LT, 00013A11L, 13A11L09F, 11008835, 00013A11F, 00000011L, 00013H11L, 00011L09F, 13A11L09L, 00011L09L, 13V11L09L

Other

RA RA-81917

Model Numbers

00013A11LT, 00013A11L, 13A11L09F, 11008835, 00013A11F, 00000011L, 00013H11L, 00011L09F, 13A11L09L, 00011L09L, 13V11L09L

Recall Numbers

81917

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00013A11LT

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00013A11L

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 13A11L09F

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 11008835

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00013A11F

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00000011L

Product 7

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00013H11L

Product 8

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00011L09F

Product 9

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 13A11L09L

Product 10

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 00011L09L

Product 11

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 13V11L09L

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Steris.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81917

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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