Ethicon Endo Surgery, LLC recalls PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
- Recall date
- March 7, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1514-2025
- FDA classification
- Class II
- Brand / firm
- Ethicon Endo Surgery, LLC
- Sold / distributed
- 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.
Why it was recalled
Identified curing issues with the silicone during the needles manufacturing process.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
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