GN Otometrics recalls 32 types of Gold Cup and Snap Leadwires with a 0.1mm protruding conductor that may cause electrical issues during medical testing.
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
GN Otometrics is recalling 32 different models of Gold Cup and Snap Leadwires due to a small protruding conductor that could cause electrical problems during medical testing. This issue may lead to inaccurate test results or equipment damage if the lead is not properly secured.
The lead connector has a small protrusion (0.1mm) beyond the insulation. This could cause the lead to short-circuit or become unstable when connected to medical devices, potentially leading to inaccurate test results or equipment damage during evoked potential testing.
Users of audiological, neurological, or vestibular testing equipment who own any of the 32 recalled leadwire models are affected. Healthcare professionals and patients using these devices for medical testing are at the highest risk.
Check for leadwires with the following descriptions: 24" or 40" Snap Leadwires in blue, red, green, brown, orange, white, black, or yellow. Also look for sets of 5 or 7. The product has part numbers listed in the recall notice.
Identify if your leadwire matches the 32 models listed in the recall notice, including specific lengths, colors, and set sizes.
The electrode lead connector has a protruding conductor beyond the insulation by approximately 0.1 mm, which could cause short circuits or instability during medical testing.
Check for leadwires with the 32 models listed in the recall notice, including specific lengths (24" or 40"), colors (blue, red, green, brown, orange, white, black, yellow), and set sizes (5 or 7).
The recall does not specify a remedy, so no action is required. However, you should check if your leadwire is affected and consider contacting GN Otometrics for further guidance.
We’ve drafted a message you can send GN Otometrics to request your refund or repair — edit it as you like.
Subject: Recall Z-2553-2019 — GN Otometrics GN Otometrics Hello, I own a GN Otometrics that is covered by recall Z-2553-2019 from GN Otometrics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
