Health Canada — Medical Devices · Canada · 2022-09-08 · 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 →
Reported risk: Hu-Friedy has identified that the scalpel holder )tip/head of the device) may separate from the handle for certain lots of K360 Scalpel Handles. Should the tip fall off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth, and also present a choking hazard. Recall start date: August 26, 2022
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.
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.