BALT USA, LLC: Medical Device Recall in 2022 - (Recall #: Z-0103-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

Product Classification:

Class II

Date Initiated: September 7, 2022

Date Posted: October 26, 2022

Recall Number: Z-0103-2023

Event ID: 90870

Reason for Recall:

Product pouch label does not match up with carton label

Status: Ongoing

Product Quantity: 41 impacted devices

Code Information:

Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated