Guaynabo, PR, United States
Ethicon Endo Surgery, LLC recalls
1 recall recorded since 2018, most recently on 7 March 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 March 2025
- Reason
- Identified curing issues with the silicone during the needles manufacturing process.
- 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
- Voluntary: Firm initiated
- Recall numbers
- Z-1513-2025, Z-1515-2025, Z-1516-2025, Z-1514-2025
- PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
- PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
- PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.