FDA Medical devices recall · September 30, 2026

ForeSight Elite Tissue Oximetry Cable recall

Read the official FDA notice ↗

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.

Why was it recalled?

Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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 21

Distribution

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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-3250-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.