Gyrus ACMI Classic Series Continuous Flow Resectoscope Recall 2026

Health Canada has issued a recall for the Gyrus ACMI® Classic Series Continuous Flow Resectoscope, a surgical medical device used in urological procedures. Manufactured by Gyrus Acmi, Inc., this Type II recall — identified under reference number RA-82241 — was initiated on June 10, 2026, after it was determined that the sterilization instructions provided in the device’s Instructions for Use (IFU) may not consistently render the instruments adequately sterile. Healthcare facilities across Canada that use models 188A, 188, and 194 of this device are urged to take immediate action.

What Products Are Being Recalled?

The following models of the Classic Series Continuous Flow Resectoscope are affected by this recall:

• Classic Series Continuous Flow Resectoscope — Model 188A: More than 10 lot/serial numbers affected; contact the manufacturer for the complete list.
• Classic Series Continuous Flow Resectoscope — Model 188: More than 10 lot/serial numbers affected; contact the manufacturer for the complete list.
• Classic Series Continuous Flow Resectoscope — Model 194: More than 10 lot/serial numbers affected; contact the manufacturer for the complete list.

All affected products fall under the category of General and Plastic Surgery medical devices. The manufacturer, Gyrus Acmi, Inc., is headquartered at 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States.

Why Was This Recall Issued?

The recall was initiated because certain sets of sterilization parameters outlined in the device’s Instructions for Use (IFU) have been found to be potentially inadequate. Specifically, if the sterilization steps listed in the IFU are followed as written, there is a risk that the resectoscope may not be rendered completely sterile before use in surgical procedures.

A resectoscope is a specialized endoscopic instrument inserted into the body during urological surgeries, most commonly for procedures involving the bladder, urethra, or prostate. Any failure to adequately sterilize such a device before use poses a serious infection risk to patients undergoing surgery. This type of issue is classified as a Type II recall by Health Canada, indicating that the use of the affected product may cause temporary adverse health consequences, though the probability of serious harm is considered low.

Who Is Affected?

This recall is directed at healthcare professionals and medical facilities that have purchased or are currently using the Gyrus ACMI® Classic Series Continuous Flow Resectoscope in models 188, 188A, or 194. Patients who have undergone procedures where this device was used should consult their healthcare provider if they have concerns about potential infection or complications.

The recall audience is specifically identified as healthcare professionals — hospitals, surgical centers, and urology clinics are the primary recipients of this safety alert. Individual consumers are not likely to directly possess this device.

What Should You Do?

• Healthcare facilities: Immediately identify any units of the affected models (188, 188A, or 194) in your inventory.
• Check lot/serial numbers: Since more than 10 lot or serial numbers are involved per model, contact Gyrus Acmi, Inc. directly to confirm whether your specific units are included in this recall.
• Do not use unverified units until sterilization protocols have been confirmed as adequate by the manufacturer.
• Contact the manufacturer: Reach out to Gyrus Acmi, Inc. at 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 for additional information, updated sterilization guidance, and next steps.
• Report adverse events: If any adverse health events related to the use of this device have been observed, report them to Health Canada through the official reporting portal at canada.ca.

Official Statement

According to Health Canada, ‘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.’ The recall was published by Health Canada on June 22, 2026, and falls under the classification of a Health Product Recall in the medical devices category. Healthcare providers are advised to contact the manufacturer directly for complete lot number listings and remediation instructions. For ongoing updates on this recall, visit the Health Canada Recalls and Safety Alerts database at recalls-rappels.canada.ca.