Z-0487-2025Class II

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue...

Name: Z-0487-2025 MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue...
Creator: Ethicon, Inc.
Published: 2024-10-08
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2024-10-08 / Open, Classified / root cause: manufacturing process

FDA source

ETHICON, INC. began a recall of 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... on 2024-10-08. FDA classified it as Class II and gives the reason as "Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0487-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-08
Posted: 2024-11-19
Recalling firm: Ethicon, Inc
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.
Product code: GAN Suture, Absorbable, Synthetic
Reason for recall: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 10/08/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" Letter via UPS 2nd Day Air to customers informing them that due to a manufacturing component error/mix, Monocryl Suture, Product Code Y936H, Lot TMMCQD may contain some packages with incorrect needle type/size and suture diameter/length. Customers are instructed to: 1. Examine inventory immediately and quarantine such product(s). Maintain/keep a copy of this notice with the quarantined product and your records. 2. Communicate the issue to relevant personnel, or anyone else who needs to be informed. If any product has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 800-766-5841 or email [email protected] to Sedgwick within three business days. Return the BRF even if you do not have product subject to this recall. 4. Immediately return all unused Monocryl" (poliglecaprone 25) Suture subject to this recall (Product Code Y936H, Lot TMMDQD) in inventory. To receive replacement product, return product subject to this recall no later than December 31, 2024 to Sedgwick. Any non-affected product and any product returned after the date specified will not be eligible for credit reimbursement. 5. To return product, photocopy completed BRF, place in the box with the product, and affix the pre-paid authorized shipping label. Ethicon will pay for the shipping charges only if the authorized label is used. For extra shipping labels call Sedgwick at 888-203-3152. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assistance with returning product, please contact Sedgwick at 888-203-3152 and reference Event # 2852.
Quantity in commerce: 16,524 devices
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.
Product codes and lots: Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0487-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0487-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-19

Product code GAN

K964072Class IIMonocryl (Poliglecaprone 25) Suture, UndyedETHICON, Inc. / cleared 1996-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)