FDA Device recall Z-0487-2025
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation…
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation… by Ethicon, citing due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0487-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-08 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | 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 |
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
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Identifiers
| code_info | Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0487-2025%22
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