Medline MDS3001URecalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00888277408626), received between Aug 17, 2026 and Sep 30, 2026 — classified as 170 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (54 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 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952650 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951913 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951497 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951270 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: Headache

  MAUDE report 50951059 ↗
• MalfunctionSep 30, 2026Failure to Shut Off; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950058 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949234 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948931 ↗
• MalfunctionSep 30, 2026Material Integrity Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948274 ↗
• MalfunctionSep 30, 2026High Readings

  It was reported that "PRODUCT IS REGISTERING BLOOD PRESSURE AS 60% HIGHER THAN IT IS READ AT DOCTOR'S OFFICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948221 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Failure to Pump

  Patient problems: Bone Cement Implantation Syndrome

  MAUDE report 50948189 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that READING WAS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947601 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  It was reported that MONITOR IS NOT INFLATING CUFF CORRECTLY AND NO ERROR MESSAGE IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947194 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that CUST JUST PURCHASED ITEM AND IS RECEIVING ERR 4 MESSAGE. CUSTOMER CONFIRMED CUFF IS ON PROPERLY AND STILL RECIEVES ERR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947005 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  It was reported that "LEAKING INSIDE MACHINE ITSELF".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946903 ↗
• MalfunctionSep 30, 2026Low Readings

  It was reported that "SHE BROUGHT MACHINE WITH HER OT DOCTORS OFFICE TO COMPARE READINGS AND THEY ARE CONSISTENTLY 24 POINTS OFF WHEN RUNNING."

  Patient problems: Insufficient Information

  MAUDE report 50945947 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "THE ITEM MDS3001U IS DEFECTIVE" and "SHOWS A ER4 ERROR ON LED SCREEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945839 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that ITEM GIVES WRONG PRESSURE PER MBR'S DR'S OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945253 ↗
• MalfunctionSep 30, 2026High Readings

  The report states, "Customer explained that the unit is providing inaccurate pulse readings and high readings in general. His health nurses come often and told him this is wrong."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945225 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939554 ↗
• MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938373 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937677 ↗
• MalfunctionSep 29, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936706 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934509 ↗
• MalfunctionSep 29, 2026Device Emits Odor; Overheating of Device; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934454 ↗