# FDA recall Z-1985-2023

> **Masimo Corporation** · Class II · device recall initiated 2023-04-21.

## 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.

## Distribution

US: 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, RI, 	SC, SD, TN, TX, 	UT, VA, VT, WA, WI, WV, WY   OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-1985-2023
- **Recalling firm:** Masimo Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-21
- **Report date:** 2023-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1985-2023

## Citation

> AI Analytics. FDA recall Z-1985-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1985-2023. Source: US FDA. Licensed CC0.

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