CooperSurgical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0985-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.

Product Classification:

Class II

Date Initiated: August 29, 2023

Date Posted: February 14, 2024

Recall Number: Z-0985-2024

Event ID: 93822

Reason for Recall:

Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

Status: Ongoing

Product Quantity: 127 boxes, 3 kits per box (381 kits total)

Code Information:

UDI-DI: 60888937027053, lot# 326728.

Distribution Pattern:

US Nationwide distribution in the state of MO.

Voluntary or Mandated:

Voluntary: Firm initiated