MEDLINE MDS8001BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00197344077079), received between Sep 10, 2026 and Sep 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026High Readings

  It was reported that "item 7328 Medline Blood Pressure Monitor with Bluetooth is not working properly. Member stated the readings are 25 points off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900146 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  It was reported that ¿MACHINE STOPPED WORKING TODAY AND HAS A BURNED SMELL WHEN SHE REMOVED THE BATTERY BUT IT DID NOT LOOKED BURNED. SHE REPLACED THE BATTERY AND NOW IT WON'T TURN ON AT ALL.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855310 ↗
• MalfunctionSep 10, 2026Electrical /Electronic Property Problem

  The report states, "Caller states product doesn't power up. Member has tried changing batteries as well as following instructions to make sure everything is in the right place to turn on and item is not doing that."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713482 ↗