Health Canada — Medical Devices · Canada · 2025-08-28 · 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: The issue found can cause the device to overheat during operation if the circulation pressure calibration was not performed or been performed incorrect and the low-pressure alarm is not triggered. The scope of this action is the electrical heated 88-5 washer disinfectors. Justification: the construction on steam heated devices is different and the heating elements cannot be overheated. This field action is initiated to verify that the circulation pressure in standby mode reads 0.0 kPa. If the value deviates from 0.0 kPa, the device must be recalibrated by a qualified technician to ensure safe continued clinical use. Recall start date: August 21, 2025
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.