Device recall
Z-1988-2025: Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK…
FDA device recall · Class II · BALT USA, LLC
Key facts
| Recall number (Z-number) | Z-1988-2025 |
|---|---|
| Recall event | 96787 |
| 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… |
| Product code | HCG |
| Recalling firm | BALT USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172390, K200030 |
| FEI number | 3014162263 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database