Ethicon recalls specific surgical mesh products due to potential silicone curing issues during manufacturing. Affected items have unique identifiers; contact Ethicon for details.
Identified curing issues with the silicone during the needles manufacturing process.
Ethicon is recalling a specific type of surgical mesh product because of identified curing issues with the silicone during manufacturing. This could affect the product's safety and performance during use.
The silicone in the product may have curing issues from the manufacturing process. This could lead to potential safety concerns during use, though the exact risk level is not specified in the recall.
Surgical patients and healthcare providers who use the specific Ethicon PDS PLUS VIO 30IN (75CM) USP6-0(M0.7) D/A C-1 MP product. Those most at risk are individuals with the product's unique identifiers.
Check for the product code PDP127H-14, GMDN 47362, UDI-DI 10705031047907, and lot number 104M7E on the item. This product was sold with these identifiers.
Look for the product code PDP127H-14, GMDN 47362, UDI-DI 10705031047907, and lot number 104M7E on the item.
The specific product is Ethicon PDS PLUS VIO 30IN (75CM) USP6-0(M0.7) D/A C-1 MP with product code PDP127H-14.
Check for the product code PDP127H-14, GMDN 47362, UDI-DI 10705031047907, and lot number 104M7E on the item.
The recall does not specify a remedy, so contact Ethicon directly for further instructions.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1513-2025 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1513-2025 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.