# FDA recall Z-0835-2022

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2022-03-01.

## Product

FORE-SIGHT ELITE Tissue Oximeter module, REF:  HEMFSM10

## Reason for recall

The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter  Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs).  While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a  larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

## Distribution

Worldwide distribution - US Nationwide distribution 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, WY and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, CANARY ISLANDS, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Northern Ireland, Norway, Oman,	Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0835-2022
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-01
- **Report date:** 2022-04-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2022

## Citation

> AI Analytics. FDA recall Z-0835-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0835-2022. Source: US FDA. Licensed CC0.

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