# FDA recall Z-2482-2021

> **Welch Allyn Inc** · Class II · device recall initiated 2021-07-20.

## 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

## Reason for recall

If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Afghanistan,  Andorra, Australia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Canada, Chile, China,  Colombia, Congo, Costa Rica, C¿te D'ivoire (Ivory Coast), Croatia, Cyprus, Czech Republic,  Denmark, Dominican Rep., Ecuador, Estonia, Finland, France, Frenc.Polynesia, French, Guiana, Germany, Greece, Guadeloupe, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya,  Kuwait, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Malta, Martinique,  Mexico, Monaco, Myanmar, N.Mariana Islnd, Netherlands (the), New Zealand, Norway,  Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden,  Switzerland, Taiwan, Thailand, Trinidad, Tobago, Tunisia, 

## Key facts

- **Recall number:** Z-2482-2021
- **Recalling firm:** Welch Allyn Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-20
- **Report date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Skaneateles Falls, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2021

## Citation

> AI Analytics. FDA recall Z-2482-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2482-2021. Source: US FDA. Licensed CC0.

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