FDA Device recall Z-1984-2023
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
- FDA Device
- Class II
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 by Masimo, citing TC-I tip clip sensor may produce readings outside the accuracy specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1984-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-21 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Masimo |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Reason
TC-I tip clip sensor may produce readings outside the accuracy specification.
Identifiers
| code_info | UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1984-2023%22
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