FDA recall Z-1516-2025

Ethicon Endo Surgery, LLC · Class II · device

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status: Ongoing
Initiation date: 2025-03-07
Report date: 2025-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Guaynabo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2025