[Recalled] Revolve System — Medical devices | Health Canada 2017-09-05

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the Health Canada — Medical Devices notice, the identified hazard is: This recall has been initiated due to the presence of bacterial endotoxins levels for some revolve units are above the acceptable limits as defined in the standard, USP ("medical devices - bacterial endotoxin and pyrogen tests"). The issue was self-identified/confirmed on May 4, 2017.161>

This recall concerns Medical devices products distributed in Canada and was recorded by Health Canada — Medical Devices. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Review the official notice to confirm whether your unit is affected.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.