LNCS TC-I SpO2 Ear Sensor (Masimo) - Reading Accuracy Problem (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Brand
Masimo Corporation
Lot Codes / Batch Numbers
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, 21NLV, 21NZA, 22ADM, 22BVR, 22CJE, 22CJN, 22CSZ, 22CYA, 22DBL, 22DMJ, 22DSG, 22E72, 22E91, 22EGL, 22EQD, 22EZD, 22F75, 22FHH, 22G2E, 22G68, 22GTT, 22HKY, 22HSC, 22JGD, 22JGE, 22K4N, 22K4P, 22KJM, 22KMJ, 22M7N, 22MCX, 22MZS, 22N6Y, 22N9L, 22NGX, 22NRV, 23AEY, 23AJH, 23BEK, 23BRZ, 23BSS, 23CER, E19DLJ, E20CLS, E20FNS, E20FNT, E20H1G, E20HGW, E21DYY, E21G7M, K16AER, K16DDY, K16GFA, K16JDS, K16KFD, K16KFE, K16NFF, K16NFG, K17AEV, K17AEW, K17B2G, K17BCP, K17BUY, K17CFJ, K17CFK, K17CFM, K17CFN
Products Sold
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, 21NLV, 21NZA, 22ADM, 22BVR, 22CJE, 22CJN, 22CSZ, 22CYA, 22DBL, 22DMJ, 22DSG, 22E72, 22E91, 22EGL, 22EQD, 22EZD, 22F75, 22FHH, 22G2E, 22G68, 22GTT, 22HKY, 22HSC, 22JGD, 22JGE, 22K4N, 22K4P, 22KJM, 22KMJ, 22M7N, 22MCX, 22MZS, 22N6Y, 22N9L, 22NGX, 22NRV, 23AEY, 23AJH, 23BEK, 23BRZ, 23BSS, 23CER, E19DLJ, E20CLS, E20FNS, E20FNT, E20H1G, E20HGW, E21DYY, E21G7M, K16AER, K16DDY, K16GFA, K16JDS, K16KFD, K16KFE, K16NFF,K16NFG,K17AEV, K17AEW, K17B2G, K17BCP, K17BUY, K17CFJ, K17CFK, K17CFM, K17CFN
Masimo Corporation is recalling Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 due to TC-I tip clip sensor may produce readings outside the accuracy specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
TC-I tip clip sensor may produce readings outside the accuracy specification.
Recommended Action
Per FDA guidance
On 5/17/2023, Masimo issued a Urgent: Medical Device Recall Notice via FedEx. Masimo asked consignees to take the following actions: 1. Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/ or if you have part numbers or lot numbers not included in this communication and have questions about those parts. 2. Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. 3. Complete Attachment 1, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575 by MM DD, 2023. 4. Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026