Product Wiki · Recalls · Health Canada — Medical Devices

MASKS/ KN95 MASKS WITH BIOMASS GRAPHENE (2021-04-08) — recall 62338

Health Canada — Medical Devices · Canada · 2021-04-15 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
62338
Date of alert
2021-04-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Health Canada has identified the following class I medical devices from Shandong Shengquan New Materials Co. Ltd, do not meet the manufacturer's requirements of section 10 to 20 of the Medical Devices Regulations (MDR). There is a potential that wearers could inhale graphene particles from some masks, which may pose health risks.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/masks-kn95-masks-biomass-graph

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.