Masimo Corporation 2023-06-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1986-2023
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 Recall
Issued June 28, 2023 · Masimo Corporation
In June 2023, Masimo Corporation recalled the Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
TC-I tip clip sensor may produce readings outside the accuracy specification.
What you should do
- 1 Stop using Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Masimo Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Masimo Corporation
- Category
- Health
- Recall date
- June 28, 2023
- Units affected
- Not reported
- Sold at
- US: 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, N
- Recall number
- FDA-Z-1986-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Masimo Corporation has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.