Masimo SpO2 Ear Sensor May Produce Inaccurate Oxygen Saturation Readings
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.
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 a Class II medical device recall with no reported illnesses or injuries. The hazard—inaccurate sensor readings—poses a potential risk to patient care, but no actual harm has been documented. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
The Masimo LNCS TC-I SpO2 reusable ear sensor (REF: 1895) is a medical device used to measure oxygen saturation levels in patients. Approximately 443,799 units of this sensor have been recalled due to a defect in the tip clip sensor.
The recalled sensors may produce readings that fall outside the device's specified accuracy range. This means the oxygen saturation measurements displayed to healthcare providers may not be reliable, potentially affecting clinical assessment during patient care.
The affected product was distributed to healthcare facilities across all 50 US states and to more than 50 countries worldwide. Multiple lot numbers are involved in this recall, spanning manufacturing dates from 2013 to 2023.
Healthcare facilities that have received this product should immediately discontinue use of the affected lots and identify alternative methods for measuring oxygen saturation. Consult the FDA and Masimo Corporation for guidance on managing recalled devices and obtaining replacement equipment.
The recalled product
- Product
- Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
- Manufacturer
- Masimo Corporation
- Hazard
- inaccurate-readings
- measurement-accuracy
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)00843997000048 Lot #: 13NBR
- 13NBS
- 14B96
- 14CWW
- 14GFV
- 14JFW
- 14KYQ
- 14N03
- 15C01
- 15EBB
- 15HNT
- 17DCG
- 17DCH
- 17DCJ
- 17DYJ
- 17DYK
- 17E83
- 17E84
- 17FAL
- 17FAM
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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