FDA (Devices) recall action 96461
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Identified curing issues with the silicone during the needles manufacturing process.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.
Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.
Ethicon Endo Surgery recalls approximately 1,080 surgical sutures due to silicone curing issues identified during manufacturing. The defect may affect suture performance during surgical use.
Ethicon Endo Surgery recalls ETHIBOND EXCEL surgical sutures worldwide due to curing issues with the silicone coating on the needles identified during manufacturing.