Masimo Corporation: Medical Device Recall in 2023 - (Recall #: Z-1983-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

Product Classification:

Class II

Date Initiated: April 21, 2023

Date Posted: June 28, 2023

Recall Number: Z-1983-2023

Event ID: 92371

Reason for Recall:

TC-I tip clip sensor may produce readings outside the accuracy specification.

Status: Ongoing

Product Quantity: 138,926 units

Code Information:

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, 18J35, 18JPH, 18JWM, 18K49, 18KST, 18M03,19BFG, 19CBA, 19D87, 19DZS, 19EAN, 19F47, 19GCW, 19HDJ, 19HTV, 19K3N, 19KAP, 19KPZ, 19M2U,19MKM, 19NRL, 20ABM, 20C76, 20C94, 20DAL, 20FUR, 20G2S, 20HFU, 20KMY, 20KUE, 20MNW, 20NGC,21ASU, 21CBY, 21CTU, 21E08, 21E09, 21EMQ, 21EMR, 21EYS, 21EYT, 21FUF, 21FUG, 21G2S, 21GAG,21JDD, 21JXV, 21K09, 21MAT, 21NEW, 22ADL, 22APR, 22BJM, 22C29, 22D18, 22DRN, 22FHY, 22FYS,22G1W, 22HHW, 22HYW, 22JHE, 22JZX, 22K65, 22M1A, 22M6V, 22MPZ, 22N9G, 22NHZ, 23A2J, 23AAF,23AEX, 23AJG, 23BEN, 23C5X, E20H1H, E21DYW, E21G2N, E21HCQ, E21HMJ, E21HMK, E23CVQ, R17BXM

Distribution Pattern:

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, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated