Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the… recallZ-2482-2021 · Welch Allyn Inc · initiated Jul 20, 2021

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Welch Allyn Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling design

What the company is doing

Welch Allen (a Hill Rom company) issued Urgent Medical Device Correction Letter (FA-2021-05-001-SKF-004) on 7/30/21 to: Chief Executive; Facility Administrator; Facility Engineer; Vigilance Manager; Biomedical Engineering; Medical Device Liaison Officer; Distributor mailed (with signature service) to all first-level consignees by Sedgwick (third party recall company). The letter states reason for the Field Action, risk mitigations, and Actions to be taken by the User: 1. Please share this communication with all potential users in your organization and instruct them to follow the provided Cleaning Guide for proper cleaning. 2. Do not use the device if the ring around the measurement button shows a green blinking or flashing light instead of a ready state (solid green light) and contact Hillrom Customer Service to report this issue. 3. Do not use the device if the device requires multiple power-ups prior to going to ready state (solid green light) and contact Hillrom Customer Service to report this issue. 4. If you experience an overheating probe tip, do not use the device and contact Hillrom Customer Service to report the issue. 5. Complete the attached response form and return to [email protected] within one month. Actions to be taken by the distributor: Please share with end users and/or your accounts and complete the attached response form and return to [email protected] within one month. Contact [email protected] to receive an electronic copy of this notification, response form, and further instructions for notifying your accounts. Actions being taken by Hillrom: Hillrom is in the process of updating the Braun ThermoScan Pro 6000 Instructions for Use (IFU) to include additional fluid ingress warnings. The IFU and Cleaning Guide can be found on the Hillrom website, Hillrom.com, under the Education & Documentation section of the Braun ThermoScan PRO 6000 Products page. The updated IFU will be available on the website

Recall details

Recall number: Z-2482-2021
Status: Open, Classified
Initiated by the company: Jul 20, 2021
Recalling firm: Welch Allyn Inc
Quantity: 1,036,740 units
Product code: FLL
FDA submissions: K152748
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, Turkey, Ukraine, United Kingdom, Utd.Arab Emir., Vietnam, Zimbabwe.

Product description

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

Code information (models, lots, serial numbers)

All Devices in distribution. UDI: 00732094309027 DDDYYKXXXXX DDD = 3 DIGIT JULIAN DAY (EXAMPLE - 234). YY = LAST 2 DIGITS OF JULIAN YEAR (EXAMPLE - 13) K = KEYTRONIC XXXXX = 5 DIGIT BASE 10 SERIALIZED NUMBER.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Welch Allyn, Inc. 901054
Welch Allyn, Inc. · Thermometer, electronic, clinical
2 recalls13 reports

Other devices under the same FDA submission

1 device cleared under K152748 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Welch Allyn, Inc. 901054
Welch Allyn, Inc. · Thermometer, electronic, clinical
1 recall221 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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