Ethicon Endo Surgery, LLC recalls PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP

Recalled April 9, 2025 · FDA recall Z-1513-2025 · Ethicon Endo Surgery

Hazard

Identified curing issues with the silicone during the needles manufacturing process. · FDA Class II

Units

792 units

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Ethicon Endo Surgery, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →