Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

Recall date

March 7, 2025

Source

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

Recall number

Z-1515-2025

FDA classification

Class II

Brand / firm

Ethicon Endo Surgery, LLC

Sold / distributed

Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.

Why it was recalled

Identified curing issues with the silicone during the needles manufacturing process.

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

What was recalled

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM