Recall Z-3250-2026— Becton, Dickinson and Company
Class II · Ongoing
Class II FDA medical device recall by Becton, Dickinson and Company, initiated 2026-08-11. It names one FDA 510(k) clearance: K243781. 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 flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.. Reason: Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables..
- Recalling firm
- Becton, Dickinson and Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-11
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
Reason for recall
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Data sourced from openFDA. This site is unofficial and independent of the FDA.