Masimo recalls TC-I SpO2 reusable ear sensors with specific serial numbers due to potential inaccurate blood oxygen readings. Affected units may need replacement to ensure accurate health monitoring.
TC-I tip clip sensor may produce readings outside the accuracy specification.
Masimo is recalling its TC-I SpO2 reusable ear sensors with certain serial numbers because they might give inaccurate blood oxygen readings. This could lead to incorrect health assessments if used for medical monitoring.
The TC-I tip clip sensor may produce readings outside the accuracy specification, meaning blood oxygen levels could be reported incorrectly. This might lead to improper health decisions if the device is used for medical monitoring.
Patients using the Masimo TC-I SpO2 ear sensor for blood oxygen monitoring are most at risk if the device provides inaccurate readings. The recall affects specific serial numbers sold between 2013 and 2023.
Check the serial number on the device, which is listed in the recall notice as specific combinations like 13HBT, 15DAV, and others. The product was sold with the model number TC-I SpO2, Reusable Ear Sensor, REF: 2503.
Look for the serial number on the device, which is listed in the recall notice as specific combinations like 13HBT, 15DAV, and others.
The device is the Masimo LNCS TC-I SpO2 Reusable Ear Sensor with serial numbers listed in the recall notice.
The TC-I tip clip sensor may produce readings outside the accuracy specification, which could lead to incorrect blood oxygen measurements.
No, the recall does not require immediate stoppage; the device can continue to be used but should be replaced if the serial number matches the recall list.
We’ve drafted a message you can send Masimo to request your refund or repair — edit it as you like.
Subject: Recall Z-1986-2023 — Masimo Masimo Hello, I own a Masimo that is covered by recall Z-1986-2023 from Masimo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
