Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported patient injuries or hospitalizations. The hazard—potential inaccurate SpO2 sensor readings—represents a risk of harm to patients relying on accurate oxygen saturation measurements, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor (REF: 4053, UDI-DI: 00843997009904). The recall affects sensors with specific lot numbers identified by the manufacturer.
The sensor's tip clip may produce readings that fall outside the manufacturer's accuracy specification. This could result in inaccurate oxygen saturation measurements during patient monitoring, potentially affecting the accuracy of medical assessments based on these readings.
The affected sensors have been distributed throughout the United States and to countries including Argentina, Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, the United Kingdom, and many others worldwide.
Users and healthcare facilities with affected sensor lot numbers should contact Masimo Corporation for further guidance. Medical professionals should verify the accuracy of measurements when using affected units.
The recalled product
- Product
- Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
- Manufacturer
- Masimo Corporation
- Affected units
- 138,926
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: (01)00843997009904 Lot #: E16JZJ
- E16N2C
- 17A3A
- 17AKM
- 17AKN
- 17CPV
- 17DBE
- 17E87
- 17E88
- 17FAQ
- 17GEV
- 17J13
- 17KBP
- 17KWZ
- 17MDH
- 18AEG
- 18DCE
- 18E04
- 18GNZ
- 18HKS
Distribution
Part of a larger recall action
This product is one of 4 recalled by Masimo Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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