Reported Apr 9, 2025 · Ongoing
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Ethicon Endo Surgery, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo Surgery, LLC · 475C - Suite 202 · Guaynabo, PR · 00969
Is this the product you have?
- PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
- Lot codes and dates
- Product CodeZ127H-50
- GMDN16584
- UDI-DI10705031060227
- Lot number104BQC
- Amount recalled
- 1,080 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Identified curing issues with the silicone during the needles manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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