GN Otometrics Recalls Gold Cup and Snap Leadwires Due to Conductor Defect
GN Otometrics is recalling Gold Cup and Snap Leadwires because the electrode lead connector has a protruding conductor beyond the insulation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or deaths, and the defect is a minor structural issue (0.1 mm protrusion) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
GN Otometrics is recalling Gold Cup Leadwire and Snap Leadwire products. The recall involves 4,882 units, which include 41,950 individual electrode leads supplied in 5, 7, and 10 packs. The affected products are used for evoked potential testing for audiological, neurological, and/or vestibular testing.
The recall was initiated because the electrode lead connector has a protruding conductor beyond the insulation of approximately 0.1 mm. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The products were distributed worldwide, including nationwide in the United States and in numerous other countries. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 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…
- Manufacturer
- GN Otometrics
- Category
- Medical Device — Electrode Leads
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Numbers: 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
Distribution
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