Class II — Ethicon, Inc.
| Recalling firm | ETHICON INC. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point. |
| Product | Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. |
| Quantity | 23688 units |
| Distribution | Domestic distribution nationwide. US and Puerto Rico only. |
| Initiated | 2020-01-03 |
| Classified | 2020-02-04 |
| Terminated | 2021-08-13 |
| Recall number | Z-0989-2020 |
| 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, Inc. (Z-0989-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84639/
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