Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous…
Medical device recall Z-0213-2015. Published in FDA’s Enforcement Report on Nov 19, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 19, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 21,754 units (21,222) in the U.S. and Puerto Rico) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
21,754 units (21,222) in the U.S. and Puerto Rico), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
PART_ID LOT_ID 3311 11CE2 3311 E11EA7 3311 11EMM 3311 E11EDJ 3311 11FAU 3311 11FAV 3311 11CE2 3311 11FAW 3311 11GBY 3311 11HGF 3311 11HE6 3311 11J80 3311 11JCJ 3311 11HNO 3311 11JCK 3311 11K37 3412 11MA7 3311 R11KFY 3311 11K37 3311 11KQM…
Every code shown here, 1,999 characters
PART_ID LOT_ID 3311 11CE2 3311 E11EA7 3311 11EMM 3311 E11EDJ 3311 11FAU 3311 11FAV 3311 11CE2 3311 11FAW 3311 11GBY 3311 11HGF 3311 11HE6 3311 11J80 3311 11JCJ 3311 11HNO 3311 11JCK 3311 11K37 3412 11MA7 3311 R11KFY 3311 11K37 3311 11KQM 3311 11NDZ 3311 12B95 3412 12CP1 3412 11AM7 3449 E12HR3 3450 E12HR4 3412 12CP1 3635 12KP4 3636 12KP5 3635 12KQ7 3636 12KQ8 3450 E12KJY 3449 E12KS3 3449 E12KT4 3450 E12KS4 3635 12MAG 3450 E12KT5 3450 E12MA2 3578 E12MA6 3577 E12ME6 3449 E12KS3 3450 E12KS4 3578 R12N2U 3578 E12NB2 3577 E12NA9 3578 E12NB2 3450 E12HR4 3577 R12N2W 3449 13AYG 3450 R13BRX 3450 R13BE2 3577 R12N2W 3577 E12NA9 3315 E12JS1 3635 12N17 3450 13C57 3635 12N1S 3449 E12HR3 3578 13C59 3450 13DPZ 3578 E12NB2 3578 13C59 3636 13CNZ 3635 12N1S 3449 13EPF 3635 13C4K 3449 13C56 3449 13AYG 3449 13EPF 3636 13FPN PART_ID LOT_ID SERIAL_NUMBER 3449 2062190-001 3315 E12JS1 3449 V25060 3449 V25061 3449 V25062 3449 V25063 3449 V25064 3449 V25065 3449 V25066 3449 V25067 3449 V25068 3449 V25069 3449 V25070 3449 V25071 3449 V25072 3449 V25073 3449 V25074 3449 V25075 3449 V25076 3449 V25077 3449 V25078 3449 V25079 3449 V25080 3449 V25081 3449 V25082 3449 V25083 3449 V25084 3449 V25085 3449 V25086 3449 V25087 3449 V25088 3449 V25089 3449 V25136 3449 V25152 3449 V25154 3449 V25155 3449 V25156 3449 V25158 3449 V25164 3449 V25167 3449 V25170 3449 V25172 3449 V25174 3449 V25175 3449 V25179 3449 V25181 3449 V25255 3449 V25257 3449 V25258 3449 V25259 3449 V25262 3449 V25267 3577 V14404 3577 V14422 3577 V14464 3577 V14425 3577 V14434 3577 V14457 3577 V14465 3577 V14467 3577 V16984 3577 V17047 3577 V17088 3577 V17089 3577 V17090 3577 V17091 3577 V17092 3577 V17093 3577 V17094 3577 V17095 3577 V17097 3577 V17098 3577 V17099 3577 V17102 3577 V17103 3577 V17104 3577 V17105 3577 V17106 3577 V17107 3577 V17111 3577 V19603 3577 V19612 3577 V19615 3577 V19616 3577 V19617 3577 V19618 3577 V17116 3577 V14448 3577 V14466 3577 V14402 3577 V14405 3577 V14408 3577 V14409 3577 V14410 3577 V14411 3577 V14413…
FDA’s list runs to 194,014 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 30, 2014.
- FDA classified it on Nov 13, 2014.
- FDA’s Enforcement Report published it on Nov 19, 2014.
- FDA terminated it on Mar 28, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Masimo Corporation, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 194,014 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.