CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
Monocryl" (poliglecaprone Suture recalled by Ethicon
Ethicon is recalling Monocryl" (poliglecaprone Suture, distributed in 45 states. The recall was initiated on 8 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0487-2025
- FDA event ID
- 95583
- Recalling firm
- Ethicon, Juarez, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Oct 2024
- FDA classified
- 19 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 8 Oct 2024 | Recall initiated by company | |
| 19 Nov 2024 | Classified by FDA | +42 days |
| 27 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Is Monocryl" (poliglecaprone Suture recalled?
Yes. Ethicon recalled Monocryl" (poliglecaprone Suture on 8 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0487-2025.
Why was it recalled?
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Which lots are affected?
Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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