# FDA recall Z-0103-2023

> **BALT USA, LLC** · Class II · device recall initiated 2022-09-07.

## Product

Optima Coil System      Model Number OPTI0208CSS10,     Model Number OPTI0308CSS10. Used in endovascular procedures.

## Reason for recall

Product pouch label does not match up with carton label

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.

## Key facts

- **Recall number:** Z-0103-2023
- **Recalling firm:** BALT USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-07
- **Report date:** 2022-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0103-2023

## Citation

> AI Analytics. FDA recall Z-0103-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0103-2023. Source: US FDA. Licensed CC0.

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