BALT USA, LLC: Medical Device Recall in 2022 - (Recall #: Z-1680-2022)

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 OPTI0520CSF10. For endovascular embolization.

Product Classification:

Class II

Date Initiated: July 26, 2022

Date Posted: September 14, 2022

Recall Number: Z-1680-2022

Event ID: 90724

Reason for Recall:

Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

Status: Ongoing

Product Quantity: 4 devices

Code Information:

Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470

Distribution Pattern:

U.S.: AZ and FL O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated