FDA Medical devices recall ·
MONOCRYL" (poliglecaprone 25) Suture recall
- Recall number
- Z-0487-2025
- Date
- (initiated October 8, 2024)
- Company / brand
- Ethicon, LLC
Calle Durango 2751, Juarez, N/A, Mexico - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16,524 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0487-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.