FDA Device recall Z-1983-2023
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
- FDA Device
- Class II
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 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-1983-2023 |
| 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 RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Reason
TC-I tip clip sensor may produce readings outside the accuracy specification.
Identifiers
| code_info | UDI-DI: (01)00843997009904 Lot #: E16JZJ, E16N2C, 17A3A, 17AKM, 17AKN, 17CPV, 17DBE, 17E87, 17E88, 17FAQ, 17GEV, 17J13…UDI-DI: (01)00843997009904 Lot #: E16JZJ, E16N2C, 17A3A, 17AKM, 17AKN, 17CPV, 17DBE, 17E87, 17E88, 17FAQ, 17GEV, 17J13, 17KBP,17KWZ, 17MDH, 18AEG, 18DCE, 18E04, 18GNZ, 18HKS, 18J35, 18JPH, 18JWM, 18K49, 18KST, 18M03,19BFG, 19CBA, 19D87, 19DZS, 19EAN, 19F47, 19GCW, 19HDJ, 19HTV, 19K3N, 19KAP, 19KPZ, 19M2U,19MKM, 19NRL, 20ABM, 20C76, 20C94, 20DAL, 20FUR, 20G2S, 20HFU, 20KMY, 20KUE, 20MNW, 20NGC,21ASU, 21CBY, 21CTU, 21E08, 21E09, 21EMQ, 21EMR, 21EYS, 21EYT, 21FUF, 21FUG, 21G2S, 21GAG,21JDD, 21JXV, 21K09, 21MAT, 21NEW, 22ADL, 22APR, 22BJM, 22C29, 22D18, 22DRN, 22FHY, 22FYS,22G1W, 22HHW, 22HYW, 22JHE, 22JZX, 22K65, 22M1A, 22M6V, 22MPZ, 22N9G, 22NHZ, 23A2J, 23AAF,23AEX, 23AJG, 23BEN, 23C5X, E20H1H, E21DYW, E21G2N, E21HCQ, E21HMJ, E21HMK, E23CVQ, R17BXM |
|---|
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-1983-2023%22
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