MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0940-2026.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0940-2026.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0940-2026.
PATH
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Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Path Recall FAQ
Path is the subject of a medical devices safety report: MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100). The notice was published on November 6, 2025 by the U.S. Food and Drug Administration (FDA). Approximately 0 units are potentially affected.