MEDLINE INDUSTRIES, INC. MDS4001LARecalls & reported problems
Medline Industries, Inc. · MONITOR,BP,AUTO,DIGITAL, LARGE ADULT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00884389106955), received between Sep 9, 2026 and Sep 29, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (7 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
- Computer Software Problem7
- Incorrect, Inadequate or Imprecise Result or Readings3
- Low Readings2
- Display Difficult to Read1
- Electrical /Electronic Property Problem1
- High Readings1
- Incorrect Measurement1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934720 ↗MalfunctionSep 28, 2026Incorrect Measurement
It was reported that "When she went to the doctors, they compared the readings and her top number was off by 20, and bottom was off by 10."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915494 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905753 ↗MalfunctionSep 25, 2026High Readings
It was reported that the readings are incorrect and over 200.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904159 ↗MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884273 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "FOR THE PAST 2 WEEKS BP MONITOR HAS BEEN GIVING FALSE READINGS. STATES THT READINGS GO UP TO 300."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873416 ↗MalfunctionSep 23, 2026Computer Software Problem; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873154 ↗MalfunctionSep 12, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746861 ↗MalfunctionSep 12, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746840 ↗MalfunctionSep 12, 2026Electrical /Electronic Property Problem; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746748 ↗MalfunctionSep 12, 2026Computer Software Problem; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745945 ↗MalfunctionSep 9, 2026Computer Software Problem; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699031 ↗MalfunctionSep 9, 2026Computer Software Problem; Display Difficult to Read
It was reported that keeps gettting error messages looks like a u also numbers are fading.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696473 ↗
Other System, measurement, blood-pressure, non-invasive devices
- Medline MDS5001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive747 reports
- Medline MDS4003Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive398 reports
- Medline MDS4001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive267 reports
- Medline MDS3001UMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive170 reports
- Medline MDS1001CSMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive1 recall57 reports
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- DTX(TM) PLUS DT-4812 682000Argon Critical Care Systems Singapore Pte. Ltd. · System, Measurement, Blood-Pressure, Non-Invasive86 reports
- Medline MDS7001BMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive81 reports
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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