Medline MDSTH1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00080196406404), received between May 14, 2026 and Sep 30, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 reports).

1 other recall cover devices cleared under the same FDA submission (K100488); they may or may not involve this specific model.

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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953222 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952316 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951779 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949225 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949066 ↗
• MalfunctionSep 30, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949021 ↗
• MalfunctionSep 30, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948997 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948533 ↗
• MalfunctionSep 30, 2026Low Readings

  It was reported that "THE READING ON HER THERMOMETER IS OFF. SAID SHE HAD A FEVER OF 99.3, BUT WAS GETTING A READING OF 92 WHEN USING THE EAR FEATURE."

  Patient problems: Fall

  MAUDE report 50947773 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "display on shows 'low" on temp. Language does not change."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947485 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "IS NOT GIVING ACCUATE READING. WHEN SHE HAD A FEVER THIS ONE READ NORMAL BUT WHEN SHE USED ANOTHER ONE THAT ONE READ HIGH. SHE HAS TRIED NEW BATTERIES AND STILL NOT WORKING PROPERLY."

  Patient problems: Fever

  MAUDE report 50945948 ↗
• MalfunctionSep 30, 2026Low Readings

  It was reported that "When I purchased the item, I tried to use it as a forehead, the monitor and it kept registering low." It was also reported that "I still cannot get the four head thermometer to work."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944873 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940907 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938005 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936365 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933549 ↗
• MalfunctionSep 29, 2026Incorrect Measurement; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931632 ↗
• MalfunctionSep 28, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924570 ↗
• MalfunctionSep 28, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923653 ↗
• MalfunctionSep 28, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921617 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918215 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "When you take temp with forehead vs ear part the temperatures are reading vastly different temps. The forehead temperature also reads the same for multiple different people."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915533 ↗
• MalfunctionSep 25, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903467 ↗
• MalfunctionSep 25, 2026Computer Software Problem; Failure to Shut Off

  It was reported that "PUT THE BATTERIES IN IT AND IT HASNT TURNED OFF SINCE, THE SCREEN DOES NOT GO BLACK, THE LAST TEMPATURE READING AND TIME STAYS ON 24/7 UNLESS BATTERIES ARE TAKEN OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899650 ↗
• MalfunctionSep 25, 2026Computer Software Problem

  It was reported that every time they turn on it states LO on the display.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100488. One submission often covers many models, so check the product and lot details in each record.

• Z-0689-2018 · Feb 2, 2018 · Terminated
  Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)