Class II — Ethicon Endo Surgery, LLC
| Recalling firm | ETHICON ENDO-SURGERY, LLC |
|---|---|
| Registered facility | ETHICON ENDO-SURGERY, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Identified curing issues with the silicone during the needles manufacturing process. |
| Product | PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1 |
| 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. |
| Initiated | 2025-03-07 |
| Classified | 2025-04-03 |
| Recall number | Z-1514-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ethicon Endo Surgery, LLC (Z-1514-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96461/
Alerts for ETHICON ENDO-SURGERY, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.