Z-0940-2026Class II

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

Name: Z-0940-2026 MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Creator: Path
Published: 2025-11-06
License: https://open.fda.gov/license/

Path / initiated 2025-11-06 / Open, Classified

FDA source

PATH began a recall of MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) on 2025-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0940-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-06
Posted: 2025-12-18
Recalling firm: Path
Product: MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Product code: GWJ Stimulator, Auditory, Evoked Response
Reason for recall: 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.
FDA root cause: Component change control
Action: On November 6, 2025 URGENT: MEDICAL DEVICE Field Corrective Action letters were sent to their two distributors. Actions to be taken: - Users will be asked to confirm the DPOAE protocol in use. - Verify the DPOAE Protocol used is not affected by the issue (DP1, DP2, DP3, DP4, DP17, DP18, DP19, DP20, DP21). - If any other protocol is used, please replace it by using AccuLink Software. Follow instructions in IFU to do so. - Remove all affected protocols (DP5-DP16) using AccuLink Software. Follow instructions in IFU to do so. - Complete and return the attached form to confirm these steps were followed. - The expected lifetime of the probes is two years from date of manufacture. Please put the products out of use, once this is reached.
Distribution: Domestic: WI. International: Ireland.
Product codes and lots: Part Number: 8-69-41100; UDI-DI: 04260223141355; Serial Numbers: 1008852, 1008888, 1008916, 1008925, 1008935, 1008945, 1008951, 1008957, 1008960, 1008962, 1008966, 1008967, 1008987, 1008990, 1009054, 1009065, 1009066, 1009131, 1009137, 1009138, 1009139, 1009145, 1009148, 1009155, 1009159, 1009161, 1009169, 1009184, 1009188, 1009191, 1009305, 1009315, 1009316, 1009319, 1009321, 1009322, 1009325, 1009328, 1009343, 1009352, 1009356, 1009357, 1009359, 1009366, 1009372, 1009375, 1009376, 1009386, 1009388, 1009390, 1009396, 1009399, 1009400, 1009404, 1009411, 1009415, 1009419, 1009426, 1009427, 1009432, 1009439, 1009442, 1009454, 1009456, 1009460, 1009463, 1009464, 1009468, 1009475, 1009481, 1009488, 1009494, 1009495, 1009497, 1009848, 1009855.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0940-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code GWJ

K100661Class IIEarprobePath Medical GmbH / cleared 2010-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)