SENTIERO Hearing Examination Device Recalled for Technical Distortions
PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with potential risk of harm from technical malfunction that could impact patient diagnosis and care. However, no reported illnesses, injuries, or hospitalizations have been documented, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
PATH is recalling 15 units of the SENTIERO hearing examination device (Model SOH100098, Part Number 100098) due to technical distortions that may exceed expected performance levels. The affected serial numbers range from 201015 to 201029.
The recalled devices were distributed in Florida, Missouri, Ohio, and Wisconsin. No illnesses, injuries, or adverse events have been reported associated with this recall.
Anyone who received an affected device should discontinue use and contact PATH for replacement or repair instructions.
The recalled product
- Product
- SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
- Manufacturer
- PATH
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04260223142437
- Serial Numbers: 201015-201029
Distribution
Part of a larger recall action
This product is one of 4 recalled by PATH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · PATH
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- ModerateMedical device for hearing exams recalled for technical distortion issues
FDA (Devices) · 2023-12-06
- HighMedical Device Recall: SENTIERO Hearing Screening Devices for Technical Distortions
FDA (Devices) · 2023-12-06
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