Use caution Medical device recall · FDA · Published October 7, 2019

Edwards Lifesciences Oxymetry Cable Recall: Intermittent Communication Risk

Edwards Lifesciences recalls specific oxymetry cables due to inconsistent crimping causing intermittent communication issues. Affected cables have listed serial numbers; stop using if you own one.

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

🇺🇸 FDA recall #Z-1928-2020Medical device Edwards Lifesciences ›

Use caution until it’s fixed

Intermittent communication due to inconsistent crimping of connectors onto cables.

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling certain oxymetry cables that may have inconsistent crimping, leading to intermittent communication problems. This could cause inaccurate oxygen saturation readings during medical monitoring. Read more at govinfonow.com/recall/66877-edwards-lifesciences-oxymetry-cable-recall-intermittent-communication-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66877-edwards-lifesciences-oxymetry-cable-recall-intermittent-communication-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1928-2020

Cite this page

“Edwards Lifesciences Oxymetry Cable Recall: Intermittent Communication Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66877-edwards-lifesciences-oxymetry-cable-recall-intermittent-communication-risk. Based on FDA recall #Z-1928-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1928-2020%22&limit=1).

Edwards Lifesciences, LLC recalled HemoSphere oximetry cables due to intermittent communication risks from inconsistent connector crimping, according to the FDA on October 7, 2019.

How to tell if you have it

Brand: Edwards Lifesciences
Product: Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986
UPC: 00690103196986
Serial numbers: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100
Distribution: US Nationwide (AL, CA, FL, IL, IN, MO), Germany, Netherlands, United Kingdom

The hazard

The recall addresses intermittent communication caused by inconsistent crimping of connectors onto the cables. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Other recent recalls include the Edwards EVOQUE Tricuspid Delivery System Recall (March 27, 2026), the Edwards FEM-FLEX II Femoral Arterial Cannula Recall (May 14, 2025), and the Edwards Lifesciences TruWave Vamp Pressure Monitoring Set Recall (October 4, 2023). Other recent recalls of similar products include the Medline Intermittent Latex Catheter Recall (May 4, 2026), the Medline Oxygen Masks Recall (November 21, 2025), and the AVID Medical Halyard CARDIAC CATH PACK Kit Recall (March 13, 2026).

How to tell if you have this one

Check if your oxymetry cable has a serial number from the list: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100.

Brand
Edwards Lifesciences
Product
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cable Serial Number
Identify if your oxymetry cable has a serial number from the list provided in the recall notice.
Stop Using if Affected
If your cable is on the list, stop using it immediately to prevent inaccurate oxygen saturation readings.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Illinois, Indiana, Missouri.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Oct 7, 2019Firm started the recall
May 8, 2020FDA classified it Class II
May 20, 2020Published in FDA’s Enforcement Report
Apr 27, 2021FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/66877-edwards-lifesciences-oxymetry-cable-recall-intermittent-communication-risk">Edwards Lifesciences Oxymetry Cable Recall: Intermittent Communication Risk (GovInfoNow)</a>

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-1928-2020 (October 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1928-2020 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.