# FDA recall Z-2553-2019

> **GN Otometrics** · Class II · device recall initiated 2019-08-01.

## 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;      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;      21. 24" Snap Leadwire, Set of 5;      22. 40" Snap Leadwire, Set of 5;      23. 48" Gold Cup Leadwires, Blue;      24. 48" Gold Cup Leadwires, Red;      25. 48" Gold Cup Leadwires, Green;      26. 48" Gold Cup Leadwi

## Reason for recall

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

## Distribution

Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Macedonia, The Former Yugoslav, Malaysia, Maldives, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine,

## Key facts

- **Recall number:** Z-2553-2019
- **Recalling firm:** GN Otometrics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-08-01
- **Report date:** 2019-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Taastrup, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2019

## Citation

> AI Analytics. FDA recall Z-2553-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2553-2019. Source: US FDA. Licensed CC0.

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