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Class IIOngoing

Becton, Dickinson and Company recalls ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oxim

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Becton, Dickinson and Company
Reason
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99370…

Products

  1. 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.

    Codes/lots: 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 21Quantity: 15,455 cablesRecall no. Z-3250-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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