Medline HCSM70RRecalls & reported problems
Medline Industries, Inc. · OXIMETER,PULSE,FINGERTIP,BASIC,NON- · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193489006882), received between Jun 3, 2026 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Low Readings1
- Mechanical Problem1
- Poor Visibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952213 ↗MalfunctionSep 30, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951207 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940126 ↗MalfunctionJun 3, 2026Poor Visibility
IT WAS REPORTED THAT: "THE PULSE OXIMETER DOES NOT WORK. THE LIGHT FROM THE SCREEN TURNS ON FOR A LITTLE BIT BUT THEN TURNS OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374708 ↗
Other oximeter, infrared, sporting, aviation devices
- MEDLINE HCSM70JMedline Industries, Inc. · oximeter, infrared, sporting, aviation16 reports
- Medline HCSM70TMedline Industries, Inc. · oximeter, infrared, sporting, aviation2 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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