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Masimo Corporation recall records

10 reported ongoing

10 records in this archive. Latest source date Feb 20, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive ala...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Ger...

Official source
FDA device enforcement

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive ala...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Ger...

Official source
FDA device enforcement

Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM,...

Official source

Reasons in these listed records

  • Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could del...
  • Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
  • TC-I tip clip sensor may produce readings outside the accuracy specification.

These examples come from this result page and are not a ranking of every recall reason.

Checking Masimo Corporation

Is there a recall on masimo corporation right now?

This archive contains 10 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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