Masimo LNOP TC-I Pulse Oximeter Sensor May Produce Inaccurate Readings
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.
What this means for you
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves inaccurate sensor readings on a critical patient monitoring device, which qualifies as a risk-of-harm product where no injury has been reported, meeting the High (3) severity criterion.
Plain-English summary
The Masimo LNOP TC-I SpO2 reusable ear sensor (model REF: 1794) is subject to an FDA Class II recall. The sensor may produce pulse oximetry readings outside the manufacturer's accuracy specification.
Eighty-six units have been distributed throughout the United States and internationally. The affected lot numbers are K16ANC, K16MWR, K17AEU, and 17EGQ. Masimo Corporation is the recalling firm.
Pulse oximetry sensors are critical patient monitoring devices that measure blood oxygen saturation. Accurate readings are essential for clinical decision-making regarding respiratory support and oxygen therapy. Readings that fall outside the manufacturer's accuracy specification could result in unreliable oxygen level measurements.
The recalled product
- Product
- Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
- Manufacturer
- Masimo Corporation
- Hazard
- inaccurate-readings
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 (4)
- UDI-DI: (01)00843997000239 Lot #: K16ANC
- K16MWR
- K17AEU
- 17EGQ
Distribution
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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