PATH
PATH appears in FDA public data with 5 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0940-2026, Class II) was initiated on November 6, 2025.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0940-2026 | Class II | MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) | November 6, 2025 |
| Z-0403-2024 | Class II | AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 10009 | September 26, 2023 |
| Z-0401-2024 | Class II | SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 10009 | September 26, 2023 |
| Z-0402-2024 | Class II | SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part N | September 26, 2023 |
| Z-0404-2024 | Class II | SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Nu | September 26, 2023 |