ForeSight Elite Tissue Oximetry Cable
Medical device recall Z-3250-2026. Published in FDA’s Enforcement Report on Sep 30, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 30, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 15,455 cables how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
15,455 cables, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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…
FDA’s list runs to 140,522 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
50 states and territories.
Every one of them
- 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 FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 11, 2026.
- FDA classified it on Sep 21, 2026.
- FDA’s Enforcement Report published it on Sep 30, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton, Dickinson and Company, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 140,522 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.