Medical Device Screening Tool Recalled Due to Technical Distortion Issues
PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were 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 an FDA Class II medical device recall. The device is used for hearing diagnostic screening, and technical distortions could result in incorrect diagnostic results. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
PATH is recalling 28 units of SENTIERO Screening2, a mobile medical device used for hearing examinations (Model Number SOH100098, Part Number 100098-S2). The recall was initiated because affected units may experience technical distortions to a greater extent than expected.
The affected devices were distributed to facilities in Florida, Missouri, Ohio, and Wisconsin. Specific serial numbers are 290402-290403, 290405-290408, 290422-290433, 290435-290443, and 290446.
If you have a SENTIERO Screening2 device with one of these serial numbers, contact PATH or the FDA to determine whether your device is affected. Do not use the device if you suspect it may be affected by this issue.
The recalled product
- Product
- SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
- Manufacturer
- PATH
- Hazard
- Affected units
- 28
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 (6)
- UDI-DI: 04260223145377
- Serial Numbers: 290402-290403
- 290405-290408
- 290422-290433
- 290435-290443
- 290446
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
- 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
- HighSENTIERO Hearing Examination Device Recalled for Technical Distortions
FDA (Devices) · 2023-12-06
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