# FDA recall Z-1680-2022

> **BALT USA, LLC** · Class II · device recall initiated 2022-07-26.

## Product

Optima Coil System Model  OPTI0520CSF10.  For endovascular embolization.

## Reason for recall

Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

## Distribution

U.S.: AZ and FL  O.U.S.: None

## Key facts

- **Recall number:** Z-1680-2022
- **Recalling firm:** BALT USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-26
- **Report date:** 2022-09-14

- **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-1680-2022

## Citation

> AI Analytics. FDA recall Z-1680-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1680-2022. Source: US FDA. Licensed CC0.

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