Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1983-2023 — Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

U.S. FDA — Device Enforcement · United States · 2023-04-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1983-2023
Date of alert
2023-04-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Masimo Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00843997009904
Reported risk: TC-I tip clip sensor may produce readings outside the accuracy specification.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.