Z-1984-2023Class II

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

Name: Z-1984-2023 Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Creator: Masimo Corporation
Published: 2023-04-21
License: https://open.fda.gov/license/

Masimo Corporation / initiated 2023-04-21 / Open, Classified / root cause: manufacturing process

FDA source

Masimo Corporation began a recall of Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 on 2023-04-21. FDA classified it as Class II and gives the reason as "TC-I tip clip sensor may produce readings outside the accuracy specification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1984-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-21
Posted: 2023-06-21
Recalling firm: Masimo Corporation
Product: Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Product code: DQA Oximeter
Reason for recall: TC-I tip clip sensor may produce readings outside the accuracy specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 5/17/2023, Masimo issued a Urgent: Medical Device Recall Notice via FedEx. Masimo asked consignees to take the following actions: 1. Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/ or if you have part numbers or lot numbers not included in this communication and have questions about those parts. 2. Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. 3. Complete Attachment 1, then email it to [email protected], or Fax it to 1-949-297-7575 by MM DD, 2023. 4. Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
Quantity in commerce: 86 units
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, 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.
Product codes and lots: UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1984-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1983-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1984-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1985-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1986-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21

Product code DQA

K033296Class IIMasimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp. / cleared 2004-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)