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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92371

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Masimo Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1983-2023
Recall number
Z-1983-2023
Initiated
April 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Masimo Corporation
Quantity
138,926 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
TC-I tip clip sensor may produce readings outside the accuracy specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

device · product 2 of 4

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

Z-1984-2023
Recall number
Z-1984-2023
Initiated
April 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Masimo Corporation
Quantity
86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
TC-I tip clip sensor may produce readings outside the accuracy specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ

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.

device · product 3 of 4

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

Z-1985-2023
Recall number
Z-1985-2023
Initiated
April 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Masimo Corporation
Quantity
443,799 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
TC-I tip clip sensor may produce readings outside the accuracy specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, 17GER, 17GNT, 17HAV, 17HLA, 17HLB, 17HZD, 17J08,17J09, 17JRE, 17KBQ, 17KBR, 17MDD, 17MDE, 17MPD, 17N06, 17N07, 17NFD, 18A26, 18A27, 18B99, 18BAA, 18CCT, 18CWV, 18CYG, 18DCB, 18EEC, 18ENJ, 18FAG, 18G1V, 18GND, 18GUC, 18H3N, 18HVP, 18J32, 18JPJ, 18JVL, 18K47, 18K52, 18M01, 18M02, 18NAE, 19AAA, 19AHL, 19B2G, 19BFC, 19CAB, 19CAC, 19CUX, 19D83, 19DGK, 19DVR, 19EAJ, 19EAK, 19EVJ, 19F43, 19FUY, 19GCV, 19GSX, 19GZX, 19JEE, 19JVK, 19K42, 19K4V, 19KAM, 19KQB, 19M09, 19M11, 19M2V, 19NDD, 20A4H, 20ABN, 20BBT, 20BKJ, 20BWP, 20C74, 20CRU, 20DAK, 20EQM, 20F49, 20FPD, 20G31, 20G8F, 20HFV, 20HRK, 20J5J, 20JLT, 20K2C, 20KGW, 20KQS, 20MJX, 20MST, 20NGB, 20NGD, 20NUT, 21AGX, 21AXQ, 21BJG, 21BVK, 21CMG, 21DFN, 21EFA, 21EMS, 21EXD, 21EYU, 21F6J, 21FFZ, 21FUH, 21GFE, 21H2M, 21HCT, 21HUC, 21HWH, 21JDQ, 21K4B, 21KGZ, 21MUT, 21MWW, 21NEB, 21NLV, 21NZA, 22ADM, 22BVR, 22CJE, 22CJN, 22CSZ, 22CYA, 22DBL, 22DMJ, 22DSG, 22E72, 22E91, 22EGL, 22EQD, 22EZD, 22F75, 22FHH, 22G2E, 22G68, 22GTT, 22HKY, 22HSC, 22JGD, 22JGE, 22K4N, 22K4P, 22KJM, 22KMJ, 22M7N, 22MCX, 22MZS, 22N6Y, 22N9L, 22NGX, 22NRV, 23AEY, 23AJH, 23BEK, 23BRZ, 23BSS, 23CER, E19DLJ, E20CLS, E20FNS, E20FNT, E20H1G, E20HGW, E21DYY, E21G7M, K16AER, K16DDY, K16GFA, K16JDS, K16KFD, K16KFE, K16NFF,K16NFG,K17AEV, K17AEW, K17B2G, K17BCP, K17BUY, K17CFJ, K17CFK, K17CFM, K17CFN

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.

device · product 4 of 4

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

Z-1986-2023
Recall number
Z-1986-2023
Initiated
April 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Masimo Corporation
Quantity
123,745 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
TC-I tip clip sensor may produce readings outside the accuracy specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI-DI: (01)00843997003230 Lot #: 13HBT, 15DAV, 17FAN, 17HAX, 17J12, 17MDF, 17N09, 18A28, 18AVB, 18CUV, 18FQZ, 18J33, 18K48,18KSS, 18MBC, 19ALF, 19CAY, 19D84, 19HMB, 19N1C, 20CRT, 20FMM, 20KWK, 21CRG, 21EMP, 21FFY,21FWV, 21G2K, 21GTL, 21HWG, 21KGD, 21MEF, 22AVS, 22BSC, 22DGZ, 22DUG, 22ESP, 22GDZ, 22J4J,22K64, 22NYC, 23AAE, E21DXT, K16HCA, K16JFC, K17BCR

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.