Class II — ETHICON, INC.
| Recalling firm | ETHICON, LLC |
|---|---|
| Registered facility | ETHICON, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length. |
| Product | MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery. |
| Quantity | 16,524 devices |
| Distribution | U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided. |
| Initiated | 2024-10-08 |
| Classified | 2024-11-19 |
| Recall number | Z-0487-2025 |
| 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-0487-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95583/
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