Reported Jun 25, 2025 · Ongoing
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851…
Balt USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BALT USA, LLC · 29 Parker Ste 100 · Irvine, CA · 92618-1667
Is this the product you have?
100 of 100 products
| Model / number | Product as published |
|---|---|
00810068568875 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK |
00810068568882 | OPTI0158BLK |
00810068568851 | OPTI0103BLK |
00810068568929 | OPTI0258BLK |
00810068568912 | OPTI0212BLK |
00810068568905 | OPTI0206BLK |
00810068568943 | OPTI0310BLK |
00810068568950 | OPTI0320BLK |
00818053026614 | OPTI0151HSS10 |
00840303701002 | OPTI0152HSS10 |
00840303701019 | OPTI0153HSS10 |
00818053025761 | OPTI0154CSS10 |
00840303701026 | OPTI0154HSS10 |
00840303700142 | OPTI1027CST10 |
00818053027086 | OPTI1030HST10 |
00818053026461 | OPTI1034COM18 |
00818053026478 | OPTI1137COM18 |
00818053026515 | OPTI1550COM18 |
00818053025709 | OPTI0101CSS10 |
00840303700951 | OPTI0101HSS10 |
- Lot codes and dates
216 of 216 products
Products covered by this recall Model / number Barcodes Product as published OPTI0156BLK00810068568875F230800439 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK00810068568875F230800506 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK00810068568875F230800507 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK00810068568875F230800579 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK00810068568875F230800885 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK00810068568882F230800480 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK00810068568882F230800581 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK00810068568882F230800722 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK00810068568882F230800857 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK00810068568882F230800858 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK00810068568851F230800854 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK00810068568851F230800855 OptiBLOCK Coil 2.5mm x 8cm OptiBLOCK Complex OPTI0258BLK00810068568929F230800768 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK00810068568912F230800514 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK00810068568912F230800525 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK00810068568912F230800577 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK00810068568912F230800770 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK00810068568912F230800887 OptiBLOCK Coil 2mm x 6cm OptiBLOCK Complex OPTI0206BLK00810068568905F230800478 OptiBLOCK Coil 3mm x 10cm OptiBLOCK Complex OPTI0310BLK00810068568943F230800497 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex - Amount recalled
- 2889 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
This product could cause temporary or reversible health problems — stop using it.
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