The Recall Desk
HighFDA (Devices)·Z-2482-2021·Announced 2021-09-22

Braun ThermoScan PRO 6000 Ear Thermometer Recall: Burn Risk from Fluid Exposure

Braun ThermoScan PRO 6000 ear thermometers may overheat if exposed to fluids and used before drying, risking burns to the user or patient. More than 1 million units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a risk-of-harm product (potential burn injury) with no reported illnesses or injuries. Per the rubric, recalls involving theoretical risk without confirmed harm score at most 3 (High).

Plain-English summary

The Braun ThermoScan PRO 6000 Ear Thermometer (Model 6000) is being recalled by manufacturer Welch Allyn Inc. The device is intended for intermittent measurement of body temperature in professional healthcare environments, for patients ranging from newborns to geriatric adults. The recall affects more than 1 million units distributed worldwide.

The recall was issued because if the device is exposed to fluid and is used before the cleaning fluid has completely dried, the device may overheat. This overheating poses a risk of burns to the user or to the patient's ear canal.

The affected devices were distributed worldwide, including throughout the United States and to numerous countries in North America, Europe, Asia, Africa, the Middle East, and other regions.

The recalled product

Product
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
Manufacturer
Welch Allyn Inc
Category
Medical Device — Thermometer
Hazard
  • fluid-ingress
  • device-overheat
  • burn-injury

Distribution

Distributed nationwide across the United States.

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