Class IIReported 2025-12-24

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

Recalled by PATH

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.

Recall Number

Z-0940-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-06

Reported

2025-12-24

Distribution

Domestic: WI. International: Ireland.

Code Info

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.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.