Official recall record
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-03-04
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
There is already an inherent risk of a false pass with the DPOAE testing protocol with AccuScreen® for a child with a hearing disorder and this cannot be eliminated. This inherent risk of false negative answers was increased when deviating from the AccuScreen® factory default DPAOE Protocol (DP-1) using DPOAE Probe 8-69-41100.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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