Class II — ETHICON, LLC
| Recalling firm | ETHICON, LLC |
|---|---|
| Registered facility | ETHICON, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. |
| Product | PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z421H-50, Z421H-50, Z421H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z423H-50, Z423H-50, Z423H-50, Z442H-50, Z442H-50, Z442H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z489G-50, Z… |
| Quantity | 868,363 total units |
| Distribution | US Nationwide. Global Distribution. |
| Initiated | 2023-08-10 |
| Classified | 2023-09-20 |
| Recall number | Z-2617-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ETHICON, LLC (Z-2617-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92843/
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