MONOCRYL" — Class II medical device recall Z-0487-2025
Ongoing recall by ETHICON, INC., reported 2024-11-27, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and sutu
| Recall number | Z-0487-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ETHICON, INC., Juarez, N/A, Mexico |
| Recall initiated | 2024-10-08 |
| Classified | 2024-11-19 |
| Reported by FDA | 2024-11-27 |
| Distributed | 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, WY |
| Quantity | 16,524 devices |
| UPC / GTIN / UDI-DI | 10705031059917 |
| Model numbers | Y936H |
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.
Reason for recall
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0487-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.