Medical Device Recall: SENTIERO Hearing Screening Devices for Technical Distortions
PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices distributed in Florida, Missouri, Ohio, and Wisconsin.
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 is a risk-of-harm product (diagnostic medical device) where malfunction could affect test results. Although no illnesses or injuries have been reported, the potential for harm elevates this above precautionary recalls. FDA Class II classification without hospitalization reports prevents a higher severity score.
Plain-English summary
PATH has issued a recall for SENTIERO SCREENING hearing examination devices (Model Number SOH100098, Part Number 100098-S, Serial Number 280117, UDI-DI 04260223142475).
Affected units may experience technical distortions to a greater extent than expected. The recalled devices were distributed to healthcare facilities in Florida, Missouri, Ohio, and Wisconsin.
No illnesses or injuries have been reported in connection with this issue. Healthcare providers and patients who have received or used these devices are advised to contact PATH regarding this recall.
The recalled product
- Product
- SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
- Manufacturer
- PATH
- Hazard
- Affected units
- 1
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: 04260223142475
- Serial Numbers: 280117
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
See all →- HighNewborn hearing screening probes recalled over the potential for false passes
FDA (Devices) · 2025-12-24
- HighMedical Device Screening Tool Recalled Due to Technical Distortion Issues
FDA (Devices) · 2023-12-06
- ModerateMedical device for hearing exams recalled for technical distortion issues
FDA (Devices) · 2023-12-06
- HighSENTIERO Hearing Examination Device Recalled for Technical Distortions
FDA (Devices) · 2023-12-06
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