Welch Allyn Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Welch Allyn Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Welch Allyn Inc is recalling Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body t due to 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 potent. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 HillromSKF004@stericycle.com 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 HillromSKF004@stericycle.com within one month. Contact HillromSKF004@stericycle.com 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
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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