ForeSight Elite Tissue Oximetry Cable
The ForeSight Elite Tissue Oximetry Cable has incorrect switching of channels 1 and 2 on the module and flag labels.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Becton, Dickinson and Company began a recall of the ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code 00690103210927 on August 11, 2026, due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. The FDA added the recall to its Enforcement Report on September 21, 2026.
The 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, and to monitor relative changes of total hemoglobin of blood under the sensors, allowing display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable
- UDI-DI
- 00690103210927
- 10026986001
- 10026986002
- 10026986003
- 10034992001
- 21101894
- 21101342
- 21101444
- 10034992003
- 21103817
- 21103821
- 21103822
- 21103690
- 21103691
- 21103689
- 21103594
- 21103621
- 21103632
- 21103633
- 21103634
Details
- Company began the recall
- Sold in
Worldwide - U.S Nationwide distribution including in the states of 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, PR, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. The country of Grand Cayman.
- Event ID
- 99370
- Recall No.
- Z-3250-2026
- Company
- Becton, Dickinson and CompanyIrvine, California
- Hazard
- Labeling error
- Quantity recalled
- 15,455 cables
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
