PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
FDA Recall #Z-1514-2025 — Class II — March 7, 2025
Product Description
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
Recalling Firm
Ethicon Endo Surgery, LLC — Guaynabo, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,080 units
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.
Code Information
Product Code: Z127H-50; GMDN: 16584; UDI-DI: 10705031060227; Lot number: 104BQC;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated