Medline HCSM70SRecalls & reported problems
Medline Industries, Inc. · OXIMETER,PULSE,FINGERTIP,SOFT-TOUCH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10193489013542), received between Apr 28, 2026 and Sep 16, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings11
- Unable to Obtain Readings7
- Incorrect Measurement3
- Break2
- Display or Visual Feedback Problem2
- Electrical /Electronic Property Problem2
- Unexpected Shutdown2
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796173 ↗MalfunctionSep 15, 2026Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779291 ↗MalfunctionSep 15, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770809 ↗MalfunctionSep 14, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763085 ↗MalfunctionSep 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747790 ↗MalfunctionSep 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746625 ↗MalfunctionSep 4, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50613282 ↗MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50613160 ↗MalfunctionAug 31, 2026Display or Visual Feedback Problem; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531193 ↗MalfunctionAug 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525635 ↗MalfunctionAug 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525618 ↗MalfunctionAug 28, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495821 ↗MalfunctionAug 25, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439860 ↗MalfunctionAug 24, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419655 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418489 ↗MalfunctionAug 24, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416036 ↗MalfunctionAug 24, 2026Electrical /Electronic Property Problem; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411732 ↗MalfunctionAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379341 ↗MalfunctionAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374901 ↗MalfunctionAug 20, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355426 ↗MalfunctionAug 20, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355122 ↗MalfunctionAug 20, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50353648 ↗MalfunctionAug 19, 2026Circuit Failure; Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327503 ↗MalfunctionAug 19, 2026Failure to Shut Off
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324010 ↗MalfunctionAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322140 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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