ForeSight Oximeter Cable Recalled Over Mislabeled Sensors: Health Canada

Health Canada has classified a recall of the ForeSight™ Oximeter Cable, model HEMFSM10, manufactured by Edwards Lifesciences LLC, as a Type II health product recall after the company discovered a manufacturing defect that could cause the device to display swapped left-and-right oxygen saturation readings. The recall, dated August 11, 2026, was published under identification number RA-82518 and carries a healthcare-only audience designation.

The ForeSight™ Oximeter Cable is used with cerebral and somatic tissue oximetry monitors to measure regional oxygen saturation, known as StO2, in patients undergoing surgery or intensive care. According to Health Canada, the issue stems from a labelling error introduced during manufacturing rather than a defect in the sensor technology itself.

What Went Wrong?

Edwards Lifesciences identified that the laterality identification labels on the device’s green cables may be missing or incorrectly placed. In some cases, the label meant for the channel 1 cable may have been swapped with the label for channel 2, and vice versa. Because the labels tell clinicians which side of the body each cable is monitoring, a swap like this can cause the monitor to display data for the opposite region than what the label indicates.

In practical terms, a clinician relying on the displayed values could believe they are viewing readings from the right side of a patient’s brain or tissue when the numbers actually correspond to the left side, or the reverse. Health Canada notes that this mismatch creates a potential for incorrect diagnosis, which in turn could delay appropriate treatment for a patient whose condition depends on accurate, side-specific oxygenation data.

Which Items Are Involved?

The recall applies to a single affected product, the ForeSight™ Oximeter Cable, catalogue number HEMFSM10. No specific lot or serial number was identified as the notice lists this field as not applicable, meaning the issue is treated as a possible manufacturing variance across the product rather than a single confirmed batch.

• Product: ForeSight™ Oximeter Cable
• Model/Catalogue Number: HEMFSM10
• Manufacturer: Edwards Lifesciences LLC, Irvine, California
• Recall Class: Type II
• Recall Date: August 11, 2026
• Identification Number: RA-82518

Who Should Be Concerned?

This recall is directed at healthcare facilities and clinicians who use the ForeSight™ Oximeter Cable as part of tissue oximetry monitoring systems, rather than at individual consumers. Hospitals, surgical centres, and other care settings that have this cable in active use are the intended audience for the notice.

What Should Healthcare Providers Do?

Health Canada advises that clinicians and biomedical staff inspect the cable’s flag and sensor labels against the channel labels printed on the device housing. If either laterality label is missing, or if the flag label or sensor label does not match the corresponding channel label on the housing, users are instructed to contact Edwards Lifesciences’ Technical Support for further guidance. If, on inspection, the flag and sensor labels correctly correspond to the channel labels on the housing, Health Canada states that no further action is required and the device can continue to be used as normal.

This step-by-step verification process allows facilities to confirm whether their specific unit is affected without needing to remove functioning equipment from service unnecessarily, while still addressing units where the labelling defect is present.

Regulatory Response

Health Canada published the notice on August 21, 2026, categorizing it as a Type II recall within the Cardiovascular subcategory of medical devices. The recall was issued for Edwards Lifesciences LLC, based at 1 Edwards Way, Irvine, California, and is listed under the broader header of medical device labelling and packaging issues. The agency’s role in cases like this is to make the manufacturer’s corrective information publicly available and to monitor the completion of the correction across Canadian healthcare settings.

Facilities with questions about affected units, or that identify a labelling mismatch during inspection, are encouraged to reach out directly to Edwards Lifesciences’ Technical Support for replacement or further instructions. Additional updates on medical device recalls can be found through Health Canada’s recalls and safety alerts database.