FDAFDA · Food and drugs·Recall number Z-1513-2025
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Published April 9, 2025 · Recall initiated: March 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Identified curing issues with the silicone during the needles manufacturing process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo Surgery, LLC
- Distributor
- 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.
- Lot
- Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.