FDA-Device2026-09-30Class IIMISBRANDING
Becton Dickinson ForeSight Elite tissue oximetry cables recalled for channel labeling error
What this means
Becton Dickinson has recalled certain ForeSight Elite tissue oximetry cables due to incorrect labeling of Channel 1 and Channel 2 on the module and flag labels. This labeling error could cause clinicians to misread oxygen saturation data if the cables are connected to the wrong channels. The affected cables were distributed to hospitals and healthcare facilities.
- Check if your facility has any ForeSight Elite cables (model HEMFSM10) with the affected part and serial numbers listed in the recall notice.
- If you have affected cables, stop using them and contact Becton Dickinson for instructions on return or replacement.
- Verify correct channel assignments before using any ForeSight Elite cables currently in use.
The agency's original wording
Hazard
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Grand Cayman.
Affected count
15,455 cables
Manufactured in
17200 Laguna Canyon Rd, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3250-2026Want us to check the next one for you?
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