Reported Apr 9, 2025 · Ongoing
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
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?
- PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- Lot codes and dates
- Product Code
(1) 8706H-15(2) 8711H-16
- GMDN13909
- UDI-DI
(1) 10705031019430(2) 10705031019560
- Lot number
104E88104E891047TZ104BQ0104DA2104JAR104JPJ104SES104KHD104SER
- Product Code
- Amount recalled
- 37,080 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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