Reported Oct 2, 2019 · Ongoing
Gold Cup Leadwire and Snap Leadwire with the following component descriptions
GN Otometrics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GN Otometrics · Horskatten 9 · Taastrup · N/A
Is this the product you have?
Gold Cup Leadwire and Snap Leadwire with the following component descriptions
32 of 32 products
| # | Product as published |
|---|---|
| 1 | 24" Snap Leadwire, Blue |
| 2 | 40" Snap Leadwire, Blue |
| 3 | 24" Snap Leadwire, Red |
| 4 | 40" Snap Leadwire, Red |
| 5 | 24" Snap Leadwire, Green |
| 6 | 40" Snap Leadwire, Green |
| 7 | 24" Snap Leadwire, Brown |
| 8 | 40" Snap Leadwire, Brown |
| 9 | 24" Snap Leadwire, Orange |
| 10 | 40" Snap Leadwire, Orange |
| 11 | 24" Snap Leadwire, White |
| 12 | 40" Snap Leadwire, White |
| 13 | 24" Snap Leadwire, Black |
| 14 | 40" Snap Leadwire, Black |
| 15 | 24" Snap Leadwire, Yellow |
| 16 | 40" Snap Leadwire, Yellow |
| 17 | 24" Snap Leadwire, Set of 5 |
| 18 | 24" Snap Leadwire, Set of 7 |
| 19 | 40" Snap Leadwire, Set of 5 |
| 20 | 40" Snap Leadwire, Set of 7 |
- Lot codes and dates
32 of 32 products
Products covered by this recall # Product as published 1 7590310-24 2 7590310-40 3 7590311-24 4 7590311-40 5 7590312-24 6 7590312-40 7 7590313-24 8 7590313-40 9 7590314-24 10 7590314-40 11 7590315-24 12 7590315-40 13 7590316-24 14 7590316-40 15 7590317-24 16 7590317-40 17 7590318-24-5 18 7590318-24-7 19 7590318-40-5 20 7590318-40-7 - Amount recalled
- 4,882 units (41950 individual electrode leads supplied In 5,7 & 10 packs)
Where it was sold
Why it was recalled
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GN Otometrics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.