Medline MDS7001BRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00193489038654), received between Nov 14, 2024 and Sep 30, 2026 — classified as 1 injury, 80 malfunctions.

The most frequently reported specific device problem is “High Readings” (24 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 81 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 50952460 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952137 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948751 ↗
• MalfunctionSep 30, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948337 ↗
• MalfunctionSep 30, 2026High Readings

  It was reported that "IT WAS READING HIGHER THEN USUAL" and "HIS BLOOD PRESSURE WAS ALOT LOWER AT THE DOCTORS OFFICE COMPARED AT HOME, HE BELIEVES THIS PRODUCT IS NOT READING PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947746 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "ITEM KEEPS GIVING HER THE E3 ERROR MESSAGE" and "Th cuff will not inflate."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947138 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947068 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "Device makes a loud noise once it is turned on. Blood pressure monitor will begin measuring blood pressure but never finish."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946038 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that product always offered inaccurate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945739 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939795 ↗
• MalfunctionSep 29, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938382 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938281 ↗
• MalfunctionSep 29, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937416 ↗
• MalfunctionSep 29, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936826 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936383 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  It was reported that "The device does not stay on. Member tried turning it on, but it immediately shut off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932123 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that MONITOR WORKS AND TURNS ON BUT IT'S NOT GIVING ACCURATE READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931705 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931492 ↗
• MalfunctionSep 28, 2026Incorrect Measurement; Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926247 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924348 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "item Medline Bluetooth Digital Blood Pressure Monitor 1Ct SKU MDS7001B is defective .does not give accurate reading ."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917417 ↗
• MalfunctionSep 28, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917324 ↗
• MalfunctionSep 28, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916996 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that It gives inaccurate readings, member went into their Doctors to compare readings and they were different.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916652 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916635 ↗