Medline MDS4003Recalls & reported problems

Summary

The FDA's MAUDE database contains 398 adverse event reports that list this exact device (DI 00888277675493), received between Aug 30, 2018 and Sep 30, 2026 — classified as 3 injuries, 393 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (167 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 398 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952823 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952182 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951229 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950918 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950815 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950522 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950148 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950095 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949570 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the unit is not providing accurate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949154 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948996 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  It was reported that "item 3704/Medline Deluxe Digital Wrist Blood Pressure Monitor is defective because the battery has died 2x in the last 2 months. She also stated that the readings are incorrect, she stated that she received a reading elsewhere that was a different number than what the wrist monitor was reporting."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948709 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that "UNIT IS DISPLAYING INACCURATE NUMBERS. CHECKED VERSUS LARGER NON PORTABLE UNIT. LOOKS LIKE CALIBRATION IS WRONG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948597 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948192 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  This VMSR report summarizes 2 malfunction events that occurred during Q3 2023 (July 1, 2023 through September 30, 2023). The account reported that two MDS4003 wrist blood pressure monitors, identified by Serial Numbers (b)(6) , were displaying E1 and E4 error codes and providing inaccurate blood pressure readings during use. The customer requested replacement of both affected devices. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948037 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings

  It was reported that UNIT DOES NOT GIVE A READING AND GIVES ERROR CODE E WITH NO NUMBERS FOLLOWING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947631 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that "SHES CHANGED BATTERIES MUTIPLE TIMES, DONE ALL SUGGESTED THINGS IN THE MANUAL TO GET AN ACCURATE READING AND IT IS STILL WRONG. MEDLINE MONITOR READ 235/135 WITH A PULSE OF 9. SHE WENT TO KAISER AFERT AND HAD THEM TAKE IT AND IT WAS FINE. BP MONITOR IS INCORRECT. STATED MDS4003 IS NOT MEASURING CORRECT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947460 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  It was reported that "HER READINGS ARE INACCURATE AN DOFF BY ABOUT 20 POINTS" and "THE UNIT MAKES A FUNNY NOISE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947139 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "WHEN THEY CHANGED THE BATTERY THE MACHINE STARTED GIVING READINGS THAT WERE WRONG. IT WORKED FINE UNTIL THEY CHANGED THE BATTERIES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947069 ↗
• MalfunctionSep 30, 2026Low Readings

  It was reported that "THE MACHINE IS GIVING LOW READINGS IN THE HIGH SINGLE OR LOW DOUBLE DIGITS EVERY TIME THEY USE THE MACHINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946915 ↗
• MalfunctionSep 30, 2026High Readings

  It was reported that "Erroneously high readings."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946790 ↗
• OtherSep 30, 2026High Readings

  It was reported that the BLOOD PRESSURE MONITOR IS READING TOO HIGH. IT IS NOT READING ACCURATELY RIGHT AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946514 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "THE BLOOD PRESSURE MACHINE IS NOT READING CORRECTLY. HAS ANOTHER ONE AT HOME THAT IS MORE ACCURATE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946473 ↗
• MalfunctionSep 30, 2026High Readings

  It was reported that product is not providing proper reading. Monitor is reading very high.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946433 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the wrist blood pressure unit is giving inaccurate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946399 ↗