Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-1492-2022)

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:

EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.

Product Classification:

Class II

Date Initiated: May 25, 2022

Date Posted: August 10, 2022

Recall Number: Z-1492-2022

Event ID: 90528

Reason for Recall:

Product may be mislabeled.

Status: Ongoing

Product Quantity: 10 units

Code Information:

UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234

Distribution Pattern:

US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY

Voluntary or Mandated:

Voluntary: Firm initiated