FDA Devices recall · Reported September 22, 2021
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
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 u…
Welch Allyn Inc recalled Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of h… - a moderate-severity action.
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of h… was recalled by Welch Allyn Inc in September 22, 2021. Reason: If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there i…. Check the official notice for the remedy. Verify recall #Z-2482-2021 with the FDA Devices before acting.
The recall
Welch Allyn Inc issued this moderate-severity FDA Devices recall-If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there i….
- Moderate
- severity level
- 1.0M units
- affected scope
- Class II
- classification
- September 22, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2482-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) places it in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2482-2021 |
| Date reported | September 22, 2021 |
| Date initiated | July 20, 2021 |
| Recalling firm | Welch Allyn Inc |
| Firm location | Skaneateles Falls, NY |
| Affected scope | 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2482-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026