Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 — Class II medical device recall Z-0992-2020
Terminated recall by Cardinal Health 200, LLC, reported 2020-02-12, distributed nationwide. The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ens
| Recall number | Z-0992-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Mansfield, MA, United States |
| Recall initiated | 2019-10-28 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2022-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IR, IT, KR, KW, LU, MX, NL, NO, NZ, PA, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 3,619 ous |
| Model numbers | 303062 |
Product
Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
Reason for recall
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
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-0992-2020. 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.