ForeSight™ Oximeter Cable Recall
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Health Canada recalls the ForeSight™ Oximeter Cable (model HEMFSM10) due to potential mislabeled sensor cables that may cause inaccurate StO2 readings and incorrect diagnosis.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on August 21, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.
What Happened
This recall is regarding inaccurate StO2 readings from the HEMFSM10 ForeSight™ Oximeter Cable due to mispositioning of the sensor cables. Edwards has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device. There is potential that the labels on the green cables may have been switched, with the channel 1 cable labeled as channel 2, and the channel 2 cable labeled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables. Should this potential issue occur during use, the values displayed on the monitor will be switched and will represent the opposite region being monitored. Therefore, there is a potential for incorrect diagnosis, leading to potential delay of appropriate treatment.
Which Products Are Affected
ForeSight™ Oximeter Cable, model or catalogue number HEMFSM10. Lot or serial number: Not applicable.
What You Should Do
If either of the labels are missing, or the flag label and/or the sensor label do not match the channel label on the housing, contact the Technical Support. If the flag and sensor labels correctly correspond to the channel labels, there is no further action required.
Why This Matters
The potential for switched left and right values creates a risk of incorrect diagnosis and delay of appropriate treatment.
Source
https://recalls-rappels.canada.ca/en/alert-recall/foresighttm-oximeter-cable - Health Canada
Original source: Health Canada Official Notice ↗
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