Medline MDS3003Recalls & reported problems
Medline Industries, Inc. · MONITOR,BP,WRIST,DIGITAL UNIT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10080196525188), received between Sep 8, 2026 and Sep 30, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (20 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
- Computer Software Problem20
- Incorrect, Inadequate or Imprecise Result or Readings7
- Inflation Problem6
- Unable to Obtain Readings6
- High Readings5
- Gas/Air Leak3
- Incorrect Measurement3
- Device Provides Uninformative Message2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Computer Software Problem; Display or Visual Feedback Problem; Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952250 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950467 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948281 ↗MalfunctionSep 30, 2026Incorrect Measurement
It was reported that BP MACHINE WILL NOT GIVE AN ACCURATE READING. RN DRIED IT ON HERSELF AND THE NUMBERS DO NOT READ PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945860 ↗MalfunctionSep 29, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938811 ↗MalfunctionSep 29, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934699 ↗MalfunctionSep 28, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926612 ↗MalfunctionSep 28, 2026Computer Software Problem; Unable to Obtain Readings
It was reported that "THE BLOOD PRESSURE WRIST MONITOR IS READING ERRORS. NOT GIVING READINGS. CUSTOMER TRIED IT 4 TIMES ON DIFFERENT PATIENTS AND STILL NOT WORKING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914310 ↗MalfunctionSep 26, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909442 ↗MalfunctionSep 25, 2026Device Provides Uninformative Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905998 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904387 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "WRONG READINS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896230 ↗MalfunctionSep 24, 2026Computer Software Problem
It was reported that "BP MACHINE WILL NOT WORK IT CONTINUES TO SHOW ERROR MESSAGES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883682 ↗MalfunctionSep 23, 2026Computer Software Problem; Low Readings
It was reported that "THE BPM KEEPS GETTING ERROR CODE 4."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871736 ↗MalfunctionSep 23, 2026Computer Software Problem
It was reported that "Machines will inflate then show er4 code."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868663 ↗MalfunctionSep 23, 2026High Readings
This VMSR report summarizes 2 malfunction events that occurred between April 1 and June 30, 2024. The account reported that automatic digital blood pressure monitors with wrist cuffs (MDS3003) displayed blood pressure readings that were significantly higher than expected. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867016 ↗MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "Customer has found the readings to be very inconsistent and inaccurate - mainly excessively high blood pressure and heart rates."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858752 ↗MalfunctionSep 22, 2026Computer Software Problem; Inflation Problem; Unable to Obtain Readings
It was reported that "THE BP MONITOR DOES NOT WORK, IT TURNS ON BUT THEN READ ERROR. IT WILL NOT INFLATE, CHANGED BATTERIES STILL SAME ISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857978 ↗MalfunctionSep 22, 2026High Readings
It was reported that two BP moniotors reading high on all patients.When compared to other bp machines, the patient is then in a normal range for bp.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857215 ↗MalfunctionSep 22, 2026Unable to Obtain Readings
It was reported that "IT WAS NOT GIVING THEM THE PROPER READING. IT WAS GIVING THEM ERROR" and "ONE OF OF THE ERROR THAT IT IS SHOWS IS ERROR 4."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856722 ↗MalfunctionSep 22, 2026Incorrect Measurement
It was reported that "BP MONITO DOES NOT WORK" and "BP MONITOR DOES NOT REAP BP CORRECTLY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856393 ↗MalfunctionSep 21, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848642 ↗MalfunctionSep 21, 2026Computer Software Problem; Inflation Problem; Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848311 ↗MalfunctionSep 21, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846815 ↗MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842832 ↗
Other SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE devices
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- 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 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.
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