Medline MPH6560Recalls & reported problems
Medline Industries, Inc. · CONTROL, HARMONY HI LO · Class 1
- 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 10888277675698), received between Sep 29, 2026 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “High 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- High Readings2
- Low Readings2
- Incorrect, Inadequate or Imprecise Result or Readings1
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, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951218 ↗MalfunctionSep 30, 2026High Readings; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950034 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932677 ↗MalfunctionSep 29, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932666 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.