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.

Class II

Recalling firm: Becton, Dickinson and Company
Reason for recall: Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Affected products (lot / model / serial): Catalog/Model Number: HEMFSM10 UDI-DI code: 00690103210927 Part Number: 10026986001 Serial Numbers: 1907004 1907003 Part Number: 10026986002 Serial Numbers: 1941066 1941067 1924040 1925006 1925003 1925004 1924039 1938085 1923033 1928009 Part Number: 10026986003 Serial Numbers: 1944199 1950029 2008008 2008010 2008042 2008046 2008043 2008047 2008045 2008049 1942006 2008009 1928057 1938088 Part Number: 10034992001 Serial Numbers: 21101894 21101342 21101444 Part Number: 10034992003 Serial Numbers: 21103817 21103821 21103822 21103690 21103691 21103689 21103594 21103621 21103632 21103633 21103634 21103635 21103997 21103870 21103871 21103920 21103814 21103815 21103679 21103985 21103982 21103990 21104261 21104269 21103850 21103851 21104131 21104136 21104180 21104183 21104186 21104026 21104020 21104043 21104044 21104019 21104023 21104030 21103766 21103767 21103772 21103626 21103654 21104438 21103643 21103808 21103810 21104454 21103768 21103811 21103986 21103809 21103867 21103868 21103869 21104172 21104173 21103680 21103682 21103685 21103677 21103684 21103686 21103687 21103839 21103846 21103842 21103843 21103857 21103835 21103840 21103860 21104018 21103957 21103975 21103978 21103737 21103743 21103744 21103748 21103760 21104445 21104446 21103620 21103623 21103619 21104260 21103543 21103597 21103780 21103873 21103968 21103966 21103969 21103967 21103972 21103970 21103979 21103847 21103906 21103908 21104451 21103813 21103600 21103602 21103606 21103607 21103608 21103609 21103696 21103697 21103738 21104118 21104359 21103707 21103708 21103709 21103705 21103706 21103536 21103535 21103537 21103539 21103882 21103998 21104021 21104022 21104024 21104025 21103728 21103729 21103730 21103731 21103734 21103735 21103736 21103519 21103501 21103506 21103508 21103509 21103510 21103514 21103516 21103518 21103503 21103504 21103507 21103512 21103513 21103515 21103520 21103521 21103502 21103927 21103928 21105044 21104036 21104037 21104040 21104042 21103951 21103958 21103976 21103983 21104300 21104083 21104301 21103991 21103791 21103858 21103866 21103890 21104422 21104423 21104425 21104426 21104428 21104407 21104291 21104362 21104368 21104375 21104384 21104405 21104414 21103907 21103802 21103803 21103806 21104276 21103638 21104363 21103645 21103653 21103641 21103644 21103646 21103647 21103649 21103650 21103651 21103652 21103655 21103661 21103663 21103665 21103610 21103601 21103598 21103599 21103603 21103604 21103605 21104360 21103854 21103947 21103948 21103949 21103950 21103953 21103954 21103955 21103956 21104237 21104238 21104235 21104236 21104169 21104177 21103807 21103875 21103893 21103844 21104075 21104032 21103749 21103773 21103774 21103716 21103824 21103825 21103787 21103784 21103789 21103798 21103799 21103800 21104174 21103710 21103739 21103812 21103981 21104450 21103917 21103874 21103845 21103763 21103704 21103698 21103699 21103700 21103701 21103702 21103703 21103918 21102816 21104089 21103498 21103499 21103500 21103848 21103721 21103711 21104251 21104364 21104366 21104048 21104049 21104051 21104052 21104053 21104054 21104069 21104351 21104353 21103765 21104141 21104296 21104297 21104294 21104295 21103781 21103783 21103786 21103777 21103636 21103637 21103921 21103923 21104385 21104417 21104424 21104420 21104130 21104139 21104144 21103864 21103818 21103883 21104073 21104070 21103775 21103746 21103801 21104079 21104055 21104056 21103974 21103905 21103481 21104009 21104039 21104046 21104059 21104061 21104062 21104104 21104285 21103724 21103881 21103617 21103879 21103880 21104060 21104050 21104057 21104058 21104064 21104065 21104166 21104350 21104419 21104421 21104404 21104204 21103657 21103754 21103757 21103764 21103753 21103758 21103759 21103762 21103776 21103778 21103785 21103790 21104163 21104165 21103489 21104396 21104199 21103912 21104277 Part Number: 10034992005 Serial Numbers: 21104717 21104813 21104814 21104777 21104737 21104774 21104738 21104517 21104523 21104524 21104520 21104739 21104578 21104580 21104599 21104601 21104761 21104768 2110475
Units affected: 15,455 cables
Distribution pattern: 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.
Firm location: Irvine, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-3250-2026
Recall initiated: August 11, 2026
FDA classification date: September 21, 2026
FDA report date: September 30, 2026
FDA event ID: 99370
Last updated on HTM Vibe: October 6, 2026

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