CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report
Sentiero Screening, mobile medical devices for hearing examinations recalled
Path is recalling Sentiero Screening, mobile medical devices for hearing examinations, distributed in Florida, Missouri, Ohio, Wisconsin. The recall was initiated on 26 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0404-2024
- FDA event ID
- 93275
- Recalling firm
- Path, Germering
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2023
- FDA classified
- 24 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Sep 2023 | Recall initiated by company | |
| 24 Nov 2023 | Classified by FDA | +59 days |
| 6 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected lots of product may experience technical distortions to a greater extent than expected.
Product as listed by the FDA
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Where it was distributed
US States: FL, MO, OH, WI
Questions about this recall
Why was it recalled?
Affected lots of product may experience technical distortions to a greater extent than expected.
Which lots are affected?
UDI-DI: 04260223142475; Serial Numbers: 280117
Where was it sold?
US States: FL, MO, OH, WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 93275| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sentiero Screening2, mobile medical devices for hearing examinations recalled | Path | Other | 4 states | |
| CLASS II | Sentiero, mobile medical devices for hearing examinations recalled | Path | Other | 4 states | |
| CLASS II | AuDX PRO, mobile medical devices for hearing examinations recalled | Path | Other | 4 states |
More recalls from Path
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Madsen Accuscreen Teoae/Dpoae/Abr Probe recalled by PATH | Path | Other | WI |
| Device | CLASS II | AuDX PRO, mobile medical devices for hearing examinations recalled | Path | Other | 4 states |
| Device | CLASS II | Sentiero, mobile medical devices for hearing examinations recalled | Path | Other | 4 states |
| Device | CLASS II | Sentiero Screening2, mobile medical devices for hearing examinations recalled | Path | Other | 4 states |
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