FDA recall Z-1513-2025

Ethicon Endo Surgery, LLC · Class II · device

Product

PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP

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-1513-2025