Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the… — Class II medical device recall Z-2482-2021
Ongoing recall by Welch Allyn Inc, reported 2021-09-22, distributed nationwide. If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is
| Recall number | Z-2482-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Welch Allyn Inc, Skaneateles Falls, NY, United States |
| Recall initiated | 2021-07-20 |
| Classified | 2021-09-16 |
| Reported by FDA | 2021-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AT, AU, BD, BE, BH, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, KE, KR, KW, LB, LU, MT, MX, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, TH, TN, TR, TT, TW, UA, VN, ZA |
| Quantity | 1,036,740 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00732094309027 |
| Model numbers | 6000 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2482-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.