Class II

Medical Device Recall: PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1

Ethicon Endo Surgery, LLC · March 7, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

1,080 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1514-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.