Recall Z-3250-2026 ยท MUD Oximeter, Tissue Saturation
Becton, Dickinson and Company
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 hemoglob
| Date | Sep 21, 2026 (initiated Aug 11, 2026) |
| Status | Open, Classified |
| Reason | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. |
| Root cause | Labeling mix-ups |
| Action | On 08/11/2026, an "URGENT: Medical Device Correction" letter was email or FedEx'd informing customer that, based on customer feedback, BD has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device. There is potential that the labels on the green cables may have been switched, with the channel 1 cable labeled as channel 2, and the channel 2 cable labeled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables. Customers are instructed to |
| Quantity | 15,455 cables |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Sm Edwards Lifesciences, Jul 23, 2025 |