Becton, Dickinson ForeSight Elite Tissue Oximetry Cable Recall for Incorrect Channel Switching
Becton, Dickinson and Company is recalling 15,455 ForeSight Elite Tissue Oximetry Cables due to incorrect switching of Channel 1 and 2 on the module and flag labels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used to monitor patients at risk for ischemic states. The defect (incorrect channel switching) poses a risk of harm through inaccurate monitoring, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton, Dickinson and Company is recalling 15,455 units of the ForeSight Elite Tissue Oximetry Cable (REF HEMFSM10, UDI-DI code: 00690103210927). The recall is due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
The affected cables are intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The cables are also intended to monitor relative changes of total hemoglobin of blood under the sensors and allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
The recall covers distribution in the United States, including all 50 states, the District of Columbia, Puerto Rico, and the Grand Cayman. Consumers and healthcare facilities should check their inventory for the specific part and serial numbers listed in the recall notice and contact Becton, Dickinson and Company for instructions on how to proceed.
The recalled product
- Product
- ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced…
- Manufacturer
- Becton, Dickinson and Company
- Affected units
- 15,455
Distribution
Related recalls
Same manufacturer · Becton, Dickinson and Company
See all →- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereSwan-Ganz Catheters Models 131F7 Through AIQSGF8 Recalled Nationwide
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27