Medline MDS9698LRecalls & reported problems
Medline Industries, Inc. · THERMOMETER,TEMPLE,6-10 SECOND · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888277409937), received between Sep 22, 2026 and Sep 30, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (8 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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem8
- Unable to Obtain Readings4
- Calibration Problem1
- Display or Visual Feedback Problem1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Computer Software Problem
It was reported that "We have 2 that have already stopped working giving us an error 1 message. When reviewing the user guide, this is due to it being outside of the normal temperature."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948247 ↗MalfunctionSep 30, 2026Computer Software Problem
It was reported that "THEY HAVE 2 THERMOMETERS THAT CONSISTENLY ARE RECEIVING ERRORS THEY HAVE TRIED CHANGING BATTERIES BUT STILL GET THE SAME ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946598 ↗MalfunctionSep 30, 2026Computer Software Problem
This VMSR report summarizes 8 malfunction events that occurred between April 1 and June 30, 2023. The account reported that temple thermometers (MDS9698L) displayed Error 1 codes during operation. The customer reported that 8 thermometers had exhibited the issue over a period of several months. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946482 ↗MalfunctionSep 28, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918320 ↗MalfunctionSep 28, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917035 ↗MalfunctionSep 28, 2026Display or Visual Feedback Problem
It was reported that they do not work. every time we go to use them they error out.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913218 ↗MalfunctionSep 25, 2026Unable to Obtain Readings
It was reported that "Customer is getting an error message of Error 1 which would indicate that this item is not at room temp. Customer believe this is defective as she has another one of this and has not recevived this error message before".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898547 ↗MalfunctionSep 23, 2026Computer Software Problem; Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874941 ↗MalfunctionSep 23, 2026Computer Software Problem; Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873920 ↗MalfunctionSep 23, 2026Computer Software Problem
It was reported that SCREEN IS DISPLAYING ERROR 1 MESSAGE IN RED BACKGROUND, CUSTOMER TRIED TROUBLESHOOTING WITH MANUAL AND IT STILL GIVES ERROR MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871857 ↗MalfunctionSep 23, 2026Calibration Problem
It was reported that "THEY HAVE 1 THERMOMETER THAT CONSISTENLY IS RECEIVING ERRORS THEY HAVE TRIED CHANGING BATTERIES BUT STILL GET THE SAME ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869618 ↗MalfunctionSep 23, 2026Computer Software Problem
It was reported that both of them give her a red error message. The second one started doing this within 2 weeks and she cannot use it.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867203 ↗MalfunctionSep 22, 2026Unable to Obtain Readings
It was reported that NONE OF THESE ARE REGISTERING, NOT GIVING ANY SORT OF READING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854299 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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