Medical device recalls Moderate risk

Ethicon Endo Surgery, LLC recalls ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

Recall date
March 7, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1516-2025
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

ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

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