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Gyrus acmi® classic series continuous flow resectoscope

Official notice

22 Jun 2026

MediumHealth Canada

An official Health Canada notice concerns Gyrus acmi® classic series continuous flow resectoscope. This recall action is being taken because it has been determined that some of the sets of sterilization parameters provided in the IFU may not consistently render the devices adequately sterile. Published 2026-06-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82241

Official notice

2026-06-22

The hazard

This recall action is being taken because it has been determined that some of the sets of sterilization parameters provided in the IFU may not consistently render the devices adequately sterile.

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

188A, 188, 194

Other

RA RA-82241

Model Numbers

188A, 188, 194

Recall Numbers

82241

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 188A

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 188

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 194

Risk / hazard

This recall action is being taken because it has been determined that some of the sets of sterilization parameters provided in the IFU may not consistently render the devices adequately sterile.

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

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82241

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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