Coloplast Manufacturing US, LLC: Medical Device Recall in 2023 - (Recall #: Z-1365-2023)

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:

Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

Product Classification:

Class II

Date Initiated: March 1, 2023

Date Posted: April 19, 2023

Recall Number: Z-1365-2023

Event ID: 91800

Reason for Recall:

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI/DI 05708932072595, Lot Numbers: 8887620, 8939124

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

Voluntary or Mandated:

Voluntary: Firm initiated