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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97894

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 06, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PATH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0940-2026
Recall number
Z-0940-2026
Initiated
November 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
PATH
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Domestic: WI. International: Ireland.