FDAMarch 1, 2023device

Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

coloplast manufacturingcoloplast

UPCs

05708932539173

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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