FDA Device recall Z-1986-2023
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
- FDA Device
- Class II
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 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-1986-2023 |
| 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 LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Reason
TC-I tip clip sensor may produce readings outside the accuracy specification.
Identifiers
| code_info | UDI-DI: (01)00843997003230 Lot #: 13HBT, 15DAV, 17FAN, 17HAX, 17J12, 17MDF, 17N09, 18A28, 18AVB, 18CUV, 18FQZ, 18J33,…UDI-DI: (01)00843997003230 Lot #: 13HBT, 15DAV, 17FAN, 17HAX, 17J12, 17MDF, 17N09, 18A28, 18AVB, 18CUV, 18FQZ, 18J33, 18K48,18KSS, 18MBC, 19ALF, 19CAY, 19D84, 19HMB, 19N1C, 20CRT, 20FMM, 20KWK, 21CRG, 21EMP, 21FFY,21FWV, 21G2K, 21GTL, 21HWG, 21KGD, 21MEF, 22AVS, 22BSC, 22DGZ, 22DUG, 22ESP, 22GDZ, 22J4J,22K64, 22NYC, 23AAE, E21DXT, K16HCA, K16JFC, K17BCR |
|---|
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-1986-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.