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Lower risk Medical device recall · FDA · Published March 1, 2022

Edwards Lifesciences Fore-Sight Elite Tissue Oximeter Recall: Inaccurate Low Oxygen

Edwards Lifesciences recalls Fore-Sight Elite Absolute Tissue Oximeters with model 01-06-3000 due to potential inaccurate low oxygen readings in arms/legs, which could lead to unintended medical treatments.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0834-2022Medical deviceEdwards Lifesciences ›
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Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688
✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling Fore-Sight Elite Absolute Tissue Oximeters with model number 01-06-3000 because they may show falsely low oxygen levels in arms or legs. This could cause doctors to give unnecessary treatments. The recall affects patients using these devices for monitoring oxygen levels. Read more at govinfonow.com/recall/61011-edwards-lifesciences-fore-sight-elite-tissue-oximeter-recall-inaccurate-low.

Source Summary by GovInfoNow · govinfonow.com/recall/61011-edwards-lifesciences-fore-sight-elite-tissue-oximeter-recall-inaccurate-low · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0834-2022

Cite this page

“Edwards Lifesciences Fore-Sight Elite Tissue Oximeter Recall: Inaccurate Low Oxygen.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61011-edwards-lifesciences-fore-sight-elite-tissue-oximeter-recall-inaccurate-low. Based on FDA recall #Z-0834-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0834-2022%22&limit=1).

The FDA announced on March 1, 2022, that Edwards Lifesciences, LLC is recalling the FORE-SIGHT ELITE Absolute Tissue Oximeter because StO2 values may be inaccurately low. This hazard could lead to unintended or inappropriate treatment for patients.

How to tell if you have it

  • Brand: Edwards Lifesciences
  • Product: FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000
  • Model Number: 01-06-3000
  • UDI: 10609538630009
  • Serial numbers: All Serial numbers
  • Contents: Monitor 1 EA., Accessory Kit 1 EA.
  • Units affected: 402 units

The hazard

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, specifically arms and legs. While the directional trend remains accurate, it may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has had 25 other recalls on record since July 6, 2017. Recent brand recalls include the March 27, 2026, EVOQUE Tricuspid Delivery System labeling update and the May 14, 2025, FEM-FLEX II Femoral Arterial Cannula exposed wire hazard. Other recent recalls of similar products include the NOxBOXi Nitric Oxide Delivery System (September 14, 2026) and the LH One Step Ovulation Test Device (November 22, 2025).

How to tell if you have this one

Check for the model number 01-06-3000 on the device or its packaging. The recall includes all units with this specific model and serial numbers.

  • Brand
    Edwards Lifesciences
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-0834-2022FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.; FORE-SIGHT ELITE Tissue Oximeter, Model Number 01-06-3000, UDI: 10609538630009; All Serial numbers.402 units
Z-0835-2022FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10; FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.8389 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number 01-06-3000 on the device or its packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 48 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Mar 1, 202212. FDA classified it Class II: Mar 30, 202223. Published in FDA’s Enforcement Report: Apr 6, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this device?

No, the device can continue to be used but users should check for inaccurate readings in arms or legs and consult their healthcare provider if concerns arise.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0834-2022 (March 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0834-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA