Masimo Corporation recalls Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

Recall date

April 21, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1984-2023

FDA classification

Class II

Brand / firm

Masimo Corporation

Sold / distributed

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, Colombi…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794