Drug recall
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK…
FDA recall event 96787 · Class II · BALT USA, LLC
Key facts
| Event ID | 96787 |
|---|---|
| Recall numbers | Z-1988-2025, Z-1989-2025 |
| Recalling firm | BALT USA, LLC |
| Product type | Devices |
| Products | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905…, Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | May 8, 2025 |
| Report date | Jun 25, 2025 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3014162263 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: