CooperSurgical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0504-2024)

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:

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

Product Classification:

Class II

Date Initiated: March 31, 2022

Date Posted: December 13, 2023

Recall Number: Z-0504-2024

Event ID: 93239

Reason for Recall:

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

Status: Ongoing

Product Quantity: 90 units

Code Information:

UDI-DI: 60888937016453 S/N: 309967

Distribution Pattern:

Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND

Voluntary or Mandated:

Voluntary: Firm initiated