# FDA recall Z-1988-2025

> **BALT USA, LLC** · Class II · device recall initiated 2025-05-08.

## Product

Optima Coil System REFs/UDI-DI codes:  OPTI0156BLK	00810068568875  OPTI0158BLK	00810068568882  OPTI0103BLK	00810068568851  OPTI0258BLK	00810068568929  OPTI0212BLK	00810068568912  OPTI0206BLK	00810068568905  OPTI0310BLK	00810068568943  OPTI0320BLK	00810068568950  OPTI0151HSS10	00818053026614  OPTI0152HSS10	00840303701002  OPTI0153HSS10	00840303701019  OPTI0154CSS10	00818053025761  OPTI0154HSS10	00840303701026  OPTI1027CST10	00840303700142  OPTI1030HST10	00818053027086  OPTI1034COM18	00818053026461  OPTI1137COM18	00818053026478  OPTI1550COM18	00818053026515  OPTI0101CSS10	00818053025709  OPTI0101HSS10	00840303700951  OPTI0102CSS10	00818053025716  OPTI0102HSS10	00840303700968  OPTI0103HSS10	00818053026591  OPTI0103CSS10	00818053025723  OPTI0104HSS10	00818053026607  OPTI0254CSS10	00840303700548  OPTI0255CSF10	00840303700203  OPTI0256CSS10	00818053025853  OPTI0256HSS10	00818053026737  OPTI0202HSS10	00840303701040  OPTI0203HSS10	00840303701057  OPTI0203CSS10	00818053025785  OPTI0204CSS10	008

## Reason for recall

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam.

## Key facts

- **Recall number:** Z-1988-2025
- **Recalling firm:** BALT USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-08
- **Report date:** 2025-06-25

- **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-1988-2025

## Citation

> AI Analytics. FDA recall Z-1988-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1988-2025. Source: US FDA. Licensed CC0.

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