Medline MDS9952Recalls & reported problems

Medline Industries, Inc. · THERMOMETER,DIGITAL,RECTAL,F/C,30 SEC · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888277116521), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Computer Software Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 23, 2026Computer Software Problem
It was reported that "THERMOMETER SHOWING UP ERR ONCE TAKEN OUT OF PACKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867059 ↗

Device details

UDI-DI	`00888277116521`
Brand	Medline
Model	MDS9952
Company	Medline Industries, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	K173113, K183431, K211931
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 29, 2026

Device type (GMDN): General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.