Masimo LNCS TC-I SpO2 — Class II medical device recall Z-1985-2023
Ongoing recall by Masimo Corporation, reported 2023-06-28, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. TC-I tip clip sensor may produce readings outside the accuracy specification.
| Recall number | Z-1985-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Masimo Corporation, Irvine, CA, United States |
| Recall initiated | 2023-04-21 |
| Classified | 2023-06-21 |
| Reported by FDA | 2023-06-28 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EC, ES, FI, FR, GB, HK, HR, HU, IL, IN, IS, IT, JO, JP, KE, KR, LB, MA, MT, MX, MY, NL, NO, NZ, OM, PL, PT, QA, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| Quantity | 443,799 units |
| UPC / GTIN / UDI-DI | 00843997000048 |
| Lot numbers | 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 and 165 more |
| Model numbers | 1895 |
Product
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Reason for recall
TC-I tip clip sensor may produce readings outside the accuracy specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1985-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.