# FDA recall Z-0487-2025

> **ETHICON, INC.** · Class II · device recall initiated 2024-10-08.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0487-2025
- **Recalling firm:** ETHICON, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-08
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Juarez, N/A, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2025

## Citation

> AI Analytics. FDA recall Z-0487-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0487-2025. Source: US FDA. Licensed CC0.

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