FDA Device recall Z-3250-2026
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for us…
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for us… by Becton Dickinson And, citing due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3250-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-11 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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.
Reason
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Identifiers
| code_info | Catalog/Model Number: HEMFSM10 UDI-DI code: 00690103210927 Part Number: 10026986001 Serial Numbers: 1907004 1907003 P…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 2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3250-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.