Edwards Lifesciences, LLC: Medical Device Recall in 2022 - (Recall #: Z-0834-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

Product Classification:

Class II

Date Initiated: March 1, 2022

Date Posted: April 6, 2022

Recall Number: Z-0834-2022

Event ID: 89647

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

Status: Ongoing

Product Quantity: 402 units

Code Information:

FORE-SIGHT ELITE Tissue Oximeter, Model Number 01-06-3000, UDI: 10609538630009; All Serial numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated