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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Ethicon Coated VICRYL Sutures Recalled for Needle Pull-off and Degradation

Agency Publication Date: November 7, 2024
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Summary

Ethicon, Inc. is recalling 31,032 units of Coated VICRYL Polyglactin 910 Suture (Product Number J358H) after receiving complaints of needles detaching from the suture and material breaking down. Visual inspection of returned products from the affected lot confirmed that some sutures were physically degraded inside their packaging. If you possess these sutures, stop using them immediately and contact the manufacturer or your distributor to arrange for a return or replacement.

Risk

The needles may detach during surgical use or the suture material may break, leading to surgical complications, delayed procedures, or ineffective closure of wounds. No specific injury counts were provided, though several complaints have been documented.

What You Should Do

  1. This recall affects Ethicon Coated VICRYL Polyglactin 910 Sutures with Product Number J358H and Lot Number QP2AJM. The affected Unique Device Identifiers (UDI-DI) are 10705031237308 for individual units and 30705031237302 for boxes.
  2. Stop using the recalled sutures immediately.
  3. Contact Ethicon, Inc. or your distributor to arrange for the return, replacement, or correction of the affected product.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT
Model / REF:
J358H
Lot Numbers:
QP2AJM
UDI:
10705031237308
30705031237302

Recall #: Z-0319-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95516
Status: Active
Manufacturer: Ethicon, Inc.
Sold By: International distributors
Manufactured In: United States
Units Affected: 31,032 units

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.