Class II

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

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

792 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1513-2025

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.

Ethicon Endo Surgery, LLC Medical Device Recall: PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP | SafeCheck