FDA Device recall Z-1985-2023

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

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: 1895 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-1985-2023
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: 1895

Reason

TC-I tip clip sensor may produce readings outside the accuracy specification.

Identifiers

code_info	UDI-DI: (01)00843997000048 Lot #: 13NBR, 13NBS, 14B96, 14CWW, 14GFV, 14JFW, 14KYQ, 14N03, 15C01, 15EBB, 15HNT, 17DCG,… UDI-DI: (01)00843997000048 Lot #: 13NBR, 13NBS, 14B96, 14CWW, 14GFV, 14JFW, 14KYQ, 14N03, 15C01, 15EBB, 15HNT, 17DCG, 17DCH,17DCJ, 17DYJ, 17DYK, 17E83, 17E84, 17FAL, 17FAM, 17GER, 17GNT, 17HAV, 17HLA, 17HLB, 17HZD, 17J08,17J09, 17JRE, 17KBQ, 17KBR, 17MDD, 17MDE, 17MPD, 17N06, 17N07, 17NFD, 18A26, 18A27, 18B99, 18BAA, 18CCT, 18CWV, 18CYG, 18DCB, 18EEC, 18ENJ, 18FAG, 18G1V, 18GND, 18GUC, 18H3N, 18HVP, 18J32, 18JPJ, 18JVL, 18K47, 18K52, 18M01, 18M02, 18NAE, 19AAA, 19AHL, 19B2G, 19BFC, 19CAB, 19CAC, 19CUX, 19D83, 19DGK, 19DVR, 19EAJ, 19EAK, 19EVJ, 19F43, 19FUY, 19GCV, 19GSX, 19GZX, 19JEE, 19JVK, 19K42, 19K4V, 19KAM, 19KQB, 19M09, 19M11, 19M2V, 19NDD, 20A4H, 20ABN, 20BBT, 20BKJ, 20BWP, 20C74, 20CRU, 20DAK, 20EQM, 20F49, 20FPD, 20G31, 20G8F, 20HFV, 20HRK, 20J5J, 20JLT, 20K2C, 20KGW, 20KQS, 20MJX, 20MST, 20NGB, 20NGD, 20NUT, 21AGX, 21AXQ, 21BJG, 21BVK, 21CMG, 21DFN, 21EFA, 21EMS, 21EXD, 21EYU, 21F6J, 21FFZ, 21FUH, 21GFE, 21H2M, 21HCT, 21HUC, 21HWH, 21JDQ, 21K4B, 21KGZ, 21MUT, 21MWW, 21NEB, 2

code_info

UDI-DI: (01)00843997000048 Lot #: 13NBR, 13NBS, 14B96, 14CWW, 14GFV, 14JFW, 14KYQ, 14N03, 15C01, 15EBB, 15HNT, 17DCG,…

UDI-DI: (01)00843997000048 Lot #: 13NBR, 13NBS, 14B96, 14CWW, 14GFV, 14JFW, 14KYQ, 14N03, 15C01, 15EBB, 15HNT, 17DCG, 17DCH,17DCJ, 17DYJ, 17DYK, 17E83, 17E84, 17FAL, 17FAM, 17GER, 17GNT, 17HAV, 17HLA, 17HLB, 17HZD, 17J08,17J09, 17JRE, 17KBQ, 17KBR, 17MDD, 17MDE, 17MPD, 17N06, 17N07, 17NFD, 18A26, 18A27, 18B99, 18BAA, 18CCT, 18CWV, 18CYG, 18DCB, 18EEC, 18ENJ, 18FAG, 18G1V, 18GND, 18GUC, 18H3N, 18HVP, 18J32, 18JPJ, 18JVL, 18K47, 18K52, 18M01, 18M02, 18NAE, 19AAA, 19AHL, 19B2G, 19BFC, 19CAB, 19CAC, 19CUX, 19D83, 19DGK, 19DVR, 19EAJ, 19EAK, 19EVJ, 19F43, 19FUY, 19GCV, 19GSX, 19GZX, 19JEE, 19JVK, 19K42, 19K4V, 19KAM, 19KQB, 19M09, 19M11, 19M2V, 19NDD, 20A4H, 20ABN, 20BBT, 20BKJ, 20BWP, 20C74, 20CRU, 20DAK, 20EQM, 20F49, 20FPD, 20G31, 20G8F, 20HFV, 20HRK, 20J5J, 20JLT, 20K2C, 20KGW, 20KQS, 20MJX, 20MST, 20NGB, 20NGD, 20NUT, 21AGX, 21AXQ, 21BJG, 21BVK, 21CMG, 21DFN, 21EFA, 21EMS, 21EXD, 21EYU, 21F6J, 21FFZ, 21FUH, 21GFE, 21H2M, 21HCT, 21HUC, 21HWH, 21JDQ, 21K4B, 21KGZ, 21MUT, 21MWW, 21NEB, 2

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-1985-2023%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.