Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor Recalled by Masimo Corporation Due to TC-I tip clip sensor may produce readings outside...

Date: April 21, 2023
Company: Masimo Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Masimo Corporation directly.

Affected Products

Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

Quantity: 138,926 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Masimo Corporation

Masimo Corporation has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report