Medline HCSM70TRecalls & reported problems
Medline Industries, Inc. · OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00193489094261), received between May 18, 2026 and Sep 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
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, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that ¿DEVICE WAS GIVING INACCURATE READINGS. NOT WORKING PROPERLY¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895842 ↗MalfunctionMay 18, 2026Output Problem
PER REPORT, "CUSTOMER CALLED IN STATING IT IS NOT STORING THE RESULTS, ADDITIONALLY THE DEVICE WOULD SHUT OFF AFTER 15 MINS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25208863 ↗
Other oximeter, infrared, sporting, aviation devices
- MEDLINE HCSM70JMedline Industries, Inc. · oximeter, infrared, sporting, aviation16 reports
- Medline HCSM70RMedline Industries, Inc. · oximeter, infrared, sporting, aviation4 reports
- MightySat™ Fingertip Pulse Oximeter 9700Masimo Corporation · oximeter, infrared, sporting, aviation1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page