Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Recall date

April 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1754-2025

FDA classification

Class II

Brand / firm

Numed Inc

Sold / distributed

US distribution to Pennsylvania.

Why it was recalled

Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420