Medline MDS4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 267 adverse event reports that list this exact device (DI 00888277361228), received between Oct 17, 2025 and Sep 30, 2026 — classified as 1 injury, 265 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (103 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 267 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 50952817 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951592 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950612 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948406 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "THIS ITEM WORKED ONE TIME AND THEN STOPPED GIVING A SCREEEN DISPLAY OF PULSE 188 WITH A HEART AND A U WITH A LINE THROUGH IT FOLLOWED BY THE NUMBER 8."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948344 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948041 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946711 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "READINGS ARE NOT LINING UP WITH DOCTOR'S."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946439 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings

  It was reported that "IT WILL NO LONGER WORK. HE HAS CHANGED THE BATTERIES BUT IT STILL WON'T WORK. IT WILL DISPLAY WILL LIGHT UP BUT IT WILL NOT TAKE A READING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944936 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that SCREEN WENT CLEAR, HE PUT CUFF ON, PRESSED START BUTTON, STATES IT WILL NOT PUMP AT ALL, SCREEN SHOWS MULTIPLE ITEMS AT ONCE SCRAMBLED TOGETHER. HE DID PUT IN NEW BATTERIES WITH SAME RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944852 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Inflation Problem

  It was reported that the customer was ¿NEEDING HELP WITH THE BP CUFF¿ and ¿CUSTOMER GETTING ERRO U.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944851 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  It was reported that "SHE GOT THE BP MONITOR A FEW MONTHS AGO AND IT HAS NOT WORKED YET" and "IT IS STILL THROWING THE CODE STATING THE CUFF ISNT INFLATING ENOUGH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941672 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Erratic or Intermittent Display; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938699 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938261 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937287 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936963 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936705 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936638 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936482 ↗
• MalfunctionSep 29, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935680 ↗
• MalfunctionSep 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935206 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934754 ↗
• MalfunctionSep 29, 2026Unable to Obtain Readings

  It was reported that "SCREEN WAS STUCK ON RESTING HOME SCREEN" and "STILL WAS STUCK ON HOME SCREEN, WONT GIVE READING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934634 ↗
• MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934239 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934236 ↗