Health Canada Recalls Leoni Plus Ventilator Over Overheating Component Risk

Health Canada has issued a recall for the Leoni Plus medical device after identifying that an electronic component inside the unit may overheat internally. The recall, published on July 15, 2026, was classified as a Type II recall and affects devices manufactured by Lowenstein Medical Se and Co. Kg, based in Bad Ems, Germany.

What Products Are Being Recalled?

The recall covers the ‘Leoni Plus’ device, model or catalogue number 0217001. Affected units carry serial numbers ranging from 0217004HUL45501299 to 0217004HUL99971231. The Leoni Plus is categorized under Health products – Medical devices – Anaesthesiology, indicating its use in healthcare settings involving anaesthesia and respiratory support.

Why Was This Recall Issued?

According to Health Canada, the issue stems from an electronic component within the device that may overheat internally. Overheating electronic components in medical equipment can pose risks including device malfunction, potential fire hazard, or interruption of critical therapy delivery, which is especially concerning for a device used in clinical and anaesthesiology settings.

Who Is Affected?

This recall is directed at the healthcare audience, meaning hospitals, clinics, and medical facilities that use the Leoni Plus device are affected rather than individual consumers directly. Facilities using units within the specified serial number range should take note of this alert.

What Should You Do?

Healthcare facilities and professionals who use the Leoni Plus device should verify whether their units fall within the affected serial number range from 0217004HUL45501299 to 0217004HUL99971231. If additional information is required, users are instructed to contact the manufacturer directly at SUPPORTMD@LOEWENSTEINMEDICAL.COM. Facilities should follow any additional guidance provided by Lowenstein Medical Se and Co. Kg regarding continued use, inspection, or servicing of affected devices.

Official Statement

Health Canada described the issue simply, stating that ‘an electronic component may overheat internally.’ The recall was published by Health Canada under identification number RA-82330, with an original recall date of June 25, 2026, and the notice was last updated on July 15, 2026.