Loading...
Loading...
All product recalls associated with ETHICON, LLC.
Total Recalls
10
Past Year
5
Class I (Serious)
0
Most Recent
Aug 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Potential for barb non-engagement.
Identified curing issues with the silicone during the needles manufacturing process.
Identified curing issues with the silicone during the needles manufacturing process.
Identified curing issues with the silicone during the needles manufacturing process.
Identified curing issues with the silicone during the needles manufacturing process.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.