CLASS II ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report
Lnop Tc-i SpO2, Reusable Ear Sensor recalled by Masimo
Masimo is recalling Masimo Lnop Tc-i SpO2, Reusable Ear Sensor, distributed in 52 states. The recall was initiated on 21 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1984-2023
- FDA event ID
- 92371
- Recalling firm
- Masimo, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2023
- FDA classified
- 21 Jun 2023
- Reported
- 28 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 21 Apr 2023 | Recall initiated by company | |
| 21 Jun 2023 | Classified by FDA | +61 days |
| 28 Jun 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
TC-I tip clip sensor may produce readings outside the accuracy specification.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Where it was distributed
US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Lnop Tc-i SpO2, Reusable Ear Sensor recalled?
Yes. Masimo recalled Lnop Tc-i SpO2, Reusable Ear Sensor on 21 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1984-2023.
Why was it recalled?
TC-I tip clip sensor may produce readings outside the accuracy specification.
Which lots are affected?
UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ
Where was it sold?
US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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