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Ethicon, LLC FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/Class IIAug 15, 2025Potential for barb non-engagement. |
| PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soClass IIDec 20, 2024Sutures may have an open seal on the primary packaging, due |
| ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in USClass IIDec 20, 2024Sutures may have an open seal on the primary packaging, due |
| PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissClass IIDec 20, 2024Sutures may have an open seal on the primary packaging, due |
| PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDClass IIAug 10, 2023Internal testing on returned product from this lot confirmed |
| PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, ZClass IIAug 10, 2023Internal testing on returned product from this lot confirmed |