MEDLINE RENEWAL MAXARRecalls & reported problems

Medline Industries, Inc. · SENSOR, LNCS, ADULT · Class 2

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277185326), received between May 16, 2026 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Electrical /Electronic Property Problem1
Failure to Power Up1
Intermittent Loss of Power1
Low Readings1
Unable to Obtain Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Unable to Obtain Readings; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902463 ↗
MalfunctionMay 16, 2026Failure to Power Up; Intermittent Loss of Power
IT WAS REPORTED THAT, THE SP02 SENSOR WILL TAKE A WHILE TO INITIATE OR REFUSE TO DO SOENTIRELY. WE'VE ALSO HAD REPORTS THAT THE PROBE DOESN'T LIGHT UP/TURN ONAT ALL, OR THE CONNECTOR HAS TO BE RESEATED MULTIPLE TIMES TO GET IT TO RESPOND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194831 ↗

Device details

UDI-DI	`10888277185326`
Brand	MEDLINE RENEWAL
Model	MAXAR
Company	Medline Industries, Inc.
Product code	NLF · Oximeter, reprocessed
Class	Class 2
FDA submission	K181738
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Pulse oximeter probe, reprocessed

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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All Oximeter, reprocessed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.