Device recall: Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Class II FDA enforcement event 92371. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
TC-I tip clip sensor may produce readings outside the accuracy specification.
Class II, in the words of FDA
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
Masimo Corporation started this device recall on 21 Apr 2023. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 92371 has 4 product records. The first FDA enforcement report date is 28 Jun 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,…
Recalling firm
Masimo Corporation, Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1983-2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | 138,926 units | Class II | Ongoing | 28 Jun 2023 |
| Z-1984-2023 | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 | 86 units | Class II | Ongoing | 28 Jun 2023 |
| Z-1985-2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 | 443,799 units | Class II | Ongoing | 28 Jun 2023 |
| Z-1986-2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 | 123,745 units | Class II | Ongoing | 28 Jun 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 4Median of the firm: 2
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Feb 2026 | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Device | Class II | 2 |
| 15 Feb 2024 | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | Device | Class II | 4 |
| 28 Oct 2015 | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 24 | Device | Class II | 1 |
| 30 Sep 2014 | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasiv | Device | Class II | 1 |
| 13 Mar 2013 | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1983-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 92371. https://recallregister.com/fda/ii/92371/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,…
- What quantity of product is in FDA event 92371?
- The event has 4 product records. The first record gives this quantity:
138,926 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.