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Path FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)Class IINov 6, 2025Following a component change in the DPOAE probe (speaker rep |
| SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-SClass IISep 26, 2023Affected lots of product may experience technical distortion |
| AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUPClass IISep 26, 2023Affected lots of product may experience technical distortion |
| SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2Class IISep 26, 2023Affected lots of product may experience technical distortion |
| SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098Class IISep 26, 2023Affected lots of product may experience technical distortion |