RegWardenFDA facility compliance records
Company

PATH

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2023: 1 recalls; 2025: 1 recalls201720182019202020212022120232024120252026
  • Recalls (2)

Registered facilities (1)

  • PATH FEI 3008111228 · DE

Recalls & enforcement

  • Class IIOngoing2025-11-06
    Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
  • Class IIOngoing2023-09-26
    Affected lots of product may experience technical distortions to a greater extent than expected.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “PATH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10042983-path/

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