The Recall Desk

Manufacturer

PATH

5 recalls in our database name PATH as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2025-12-24

Of the 5 recalls from PATH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-0940-2026·2025-12-24

    Newborn hearing screening probes recalled over the potential for false passes

    PATH is recalling MADSEN AccuScreen probes because distortions after a speaker replacement can mimic true DPOAE responses and may result in a false PASS outcome.

    Product
    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0402-2024·2023-12-06

    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.

    Product
    SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0404-2024·2023-12-06

    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.

    Product
    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0401-2024·2023-12-06

    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.

    Product
    SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0403-2024·2023-12-06

    Medical device for hearing exams recalled for technical distortion issues

    PATH is recalling AuDX PRO hearing examination devices because they may produce technical distortions greater than expected, which could affect diagnostic accuracy. The recall affects 23 units distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
    Category
    Medical Device
    Distribution
    4 states