Boston Scientific Corporation: Medical Device Recall in 2023 - (Recall #: Z-2229-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960

Product Classification:

Class II

Date Initiated: May 25, 2023

Date Posted: August 2, 2023

Recall Number: Z-2229-2023

Event ID: 92570

Reason for Recall:

Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

Status: Ongoing

Product Quantity: 339 units

Code Information:

GTIN: 08714729978619 Lot Number: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, 30554453 Exp. Date: 20-Oct-2025 to 3-Nov-2025

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated