CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

Madsen Accuscreen Teoae/Dpoae/Abr Probe recalled by PATH

PATH is recalling Madsen Accuscreen Teoae/Dpoae/Abr Probe (, distributed nationwide in the US. The recall was initiated on 6 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0940-2026
FDA event ID: 97894
Recalling firm: PATH, Germering
Classification: Class II
Status: Ongoing
Recall initiated: 6 Nov 2025
FDA classified: 18 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Nov 2025	Recall initiated by company
18 Dec 2025	Classified by FDA	+42 days
24 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Domestic: WI. International: Ireland.

Nationwide Wisconsin

Questions about this recall

Is Madsen Accuscreen Teoae/Dpoae/Abr Probe ( recalled?

Yes. PATH recalled Madsen Accuscreen Teoae/Dpoae/Abr Probe ( on 6 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-0940-2026.

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Domestic: WI. International: Ireland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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