Medical DeviceOct 1, 2025
ETHICON STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ recall — FDA Z-2605-2025
Potential for barb non-engagement.
Class IIFDA: OngoingETHICON, LLC
Recall history in this database
Classification mix: Class II: 6.
Medical DeviceFeb 12, 2025
Ethicon PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE recall — FDA Z-1096-2025
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…
Class IIFDA: OngoingEthicon, LLC
Medical DeviceFeb 12, 2025
Ethicon ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H recall — FDA Z-1098-2025
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…
Class IIFDA: OngoingEthicon, LLC
Medical DeviceFeb 12, 2025
Ethicon PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H recall — FDA Z-1097-2025
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…
Class IIFDA: OngoingEthicon, LLC
Medical DeviceSep 27, 2023
ETHICON PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50 recall — FDA Z-2616-2023
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Class IIFDA: OngoingETHICON, LLC
Medical DeviceSep 27, 2023
ETHICON PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05 recall — FDA Z-2617-2023
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Class IIFDA: OngoingETHICON, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Ethicon, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.