FDA (Devices) recall action 92371
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
TC-I tip clip sensor may produce readings outside the accuracy specification.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.
Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.
Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.
Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.