MEDLINE INDUSTRIES, INC. MDS4001PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888277362089), received between Sep 10, 2026 and Sep 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Computer Software Problem

  It was reported that "SCREEN IS NOT DISPOLAYING TEXT OR SHOWING PRESSURE MEASUREMENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916017 ↗
• MalfunctionSep 28, 2026Computer Software Problem; Power Problem

  It was reported that MDS4001PLUS will not give a measurement. It immediately gives the ErU error code when she presses the Start/Stop button.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913387 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the BP machine is not providing accurate readings. Per the customer the machine is providing the same readings for multiple individuals (all in the 130 range).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858199 ↗
• MalfunctionSep 21, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847522 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844033 ↗
• MalfunctionSep 21, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843135 ↗
• MalfunctionSep 21, 2026Computer Software Problem; Electrical /Electronic Property Problem

  It was reported that "1 OF THE 2 UNITS IS NOT WORKING" and "A COUPLE DAYS AGO, THERE WAS AN ERROR MESSAGE, BUT THEY CAN'T REMEMBER WHAT IT WAS. NOW, IT WON'T EVEN START." She said, "It wouldn¿t attempt to blow any air into the cuff. It does not do anything now."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840886 ↗
• MalfunctionSep 11, 2026Crack; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741079 ↗
• MalfunctionSep 11, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: Discomfort

  MAUDE report 50736339 ↗
• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735535 ↗
• MalfunctionSep 10, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722604 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718892 ↗
• MalfunctionSep 10, 2026Device Provides Uninformative Message

  It was reported that the device is producing an error message.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716535 ↗