FDAAugust 10, 2023device
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
What to do
FDA enforcement status: Ongoing
Brands named
ethicon
UPCs
107050311225741070503104795210705031048232107050310482941070503104830010705031048393107050311237861070503104844710705031123854107050311238611070503120396910705031203983
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC802025-09-11
- FDASTRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.2025-08-15
- FDAEndopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR352025-04-22
- FDAPDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP2025-03-07
- FDAPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM2025-03-07
- FDAETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH2025-03-07
- FDAPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-12025-03-07
- FDAPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.2024-12-20
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