Ethicon Endo Surgery, LLC: Device Recall
Recall #Z-1514-2025 · 03/07/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1514-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ethicon Endo Surgery, LLC
- Status
- Ongoing
- Date Initiated
- 03/07/2025
- Location
- Guaynabo, PR, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,080 units
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
Product Description
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Distribution Pattern
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.
Other Recalls by Ethicon Endo Surgery, LLC
- Class II: Risk 03/07/2025
- Class II: Risk 03/07/2025
- Class II: Risk 03/07/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.