Nonin 7500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00833166009798), received between Jan 6, 2021 and Sep 15, 2025 — classified as 4 deaths.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathSep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NONIN MEDICAL WAS CONTACTED 8/21/2025 REQUESTING THE DATA DOWNLOAD FROM THE MODEL 7500 DEVICE THAT WE MANUFACTURE. IT WAS COMMUNICATED THAT THE PATIENT PASSED AWAY AND THE DETECTIVES ARE REQUESTING THE DATA AND SPECIFICALLY LOOKING FOR ON (B)(6) 2025. NO ALLEGATION OF DEVICE MALFUNCTION. NO OTHER INFORMATION WAS PROVIDED TO NONIN MEDICAL EXCEPT THAT NOTHING HAS BEEN REPORTED THAT THE DEVICE WAS NOT WORKING. IT WAS ALARMING AND THE NURSE DID NOT RESPOND.

  Patient problems: Insufficient Information

  MAUDE report 23057182 ↗
• DeathJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NONIN WAS CONTACTED ABOUT RETRIEVING THE MEMORY DATA OUT OF THE MODEL 7500 PULSE OXIMETER FROM OUR CUSTOMER WHO PURCHASED THE DEVICE (DME). A PEDIATRIC BABY DIED WHO WAS ON A VENTILATOR AND ALSO THE PULSE OXIMTER. IT WAS COMMUNICATED TO US THAT THE FATHER WENT INTO START FEEDS AT 10PM ON DECEMBER 4TH AND FOUND BABY UNRESPONSIVE. NO OTHER INFORMATION WAS PROVIDED WHEN REQUESTED. THERE IS NO ALLEGATION OF ANY DEVICE MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 18456061 ↗
• DeathJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NONIN WAS CONTACTED ABOUT RETRIEVING THE MEMORY DATA OUT OF THE MODEL 7500 PULSE OXIMETER. IT WAS COMMUNICATED TO US FROM THE PERSON WHO CONTACTED US, THE (MOTHER) COMMUNICATED THAT THE CHILD/PATIENT IS UNDER NURSE CARE AND DURING MONITORING THE DEVICE ALARMED BUT ALLEGEDLY THE NURSE DISMISSED THE ALARM. THERE WAS A SHIFT CHANGE IN THE NURSES AND THE NEW NURSE ENDED UP CALLING 911. THERE IS NO ALLEGATION OF ANY DEVICE MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 17135713 ↗
• DeathJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INCIDENT WAS REPORTED THAT A PATIENT WENT INTO CARDIAC ARREST AT THEIR HOME, WAS THEN TRANSPORTED TO THE EMERGENCY ROOM AND SUBSEQUENTLY PASSED AWAY. A MODEL 7500 PULSE OXIMETER WAS PRESENT AT THE PATIENT'S HOME AT THE TIME OF CARDIAC ARREST. AT THE TIME THAT THE INCIDENT WAS REPORTED, THERE WAS NO INDICATION THAT THE MODEL 7500 PULSE OXIMETER CAUSED OR CONTRIBUTED TO PATIENT INJURY OR DEATH. IT WAS REPORTED THAT THE INFANT PATIENT HAD UNDERLYING HEALTH CONDITIONS AND WAS ON A VENTILATOR AT THE TIME OF CARDIAC ARREST.

  Patient problems: Cardiac Arrest

  MAUDE report 11124728 ↗