Health Canada21 Aug 2026
ForeSight™ Oximeter Cable
Health Canada published a recall notice for ForeSight™ Oximeter Cable on 21 Aug 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 21 Aug 2026
- Recall type
- Health product recall
- Companies
- Edwards Lifesciences LLC · 1 Edwards Way, Irvine, California, United States, 92614
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. 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. Additional information Details Original published date: 2026-08-21 Affected products: Affected products Lot or serial number Model or catalogue number ForeSight™ Oximeter Cable Not applicable. HEMFSM10 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.