Z-2482-2021Class II

Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body...

Name: Z-2482-2021 Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body...
Creator: Welch Allyn Inc
Published: 2021-07-20
License: https://open.fda.gov/license/

Welch Allyn Inc / initiated 2021-07-20 / Open, Classified / root cause: labeling and UDI

FDA source

Welch Allyn Inc began a recall of Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal... on 2021-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2482-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-20
Posted: 2021-09-16
Recalling firm: Welch Allyn Inc
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
Product code: FLL Continuous Measurement Thermometer
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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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
Quantity in commerce: 1,036,740 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2482-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2482-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-16

Product code FLL

K152748Class IIBraun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc) / cleared 2016-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)