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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

Halyard Surgical Suture Kits Recalled for Defective Needle Coating

Agency Publication Date: May 9, 2025
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Summary

AVID Medical, Inc. has recalled approximately 204 Halyard surgical suture kits, including the Christ Suture Kit, CABG Suture Pack, and Rapides E-Pack. The silicone coating used on the surgical needles in these kits may be defective, which can result in the needles not performing correctly or the coating coming off during a procedure. No incidents or injuries have been reported related to this issue, which affects specific lots distributed in Illinois and Louisiana.

Risk

Defective silicone coating can cause surgical needles to drag through tissue or lose their coating during use, potentially leaving silicone particles inside a patient's body or complicating surgical procedures.

What You Should Do

  1. This recall affects Halyard Christ Suture Kits (Model ADVC800-03, Lot 1640852), Halyard Suture Pack CABG (Model SILV800-01, Lot 1642454), and Halyard Rapides E-Packs (Model RPGH9472-01, Lot 1636640).
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, AVID Medical, Inc., or your distributor to arrange for the return, replacement, or correction of the affected suture kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report any issues.

Your Remedy Options

๐Ÿ“‹Other Action

Correction or removal of clinical device

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
Model / REF:
ADVC800-03
Lot Numbers:
1640852 (Exp: 2/4/2028)
UDI:
10809160450703

Recall #: Z-1741-2025

Product: Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit
Model / REF:
SILV800-01
Lot Numbers:
1642454 (Exp: 2/4/2028)
UDI:
10809160450680

Recall #: Z-1742-2025

Product: Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit
Model / REF:
RPGH9472-01
Lot Numbers:
1636640 (Exp: 1/13/2028)
UDI:
10809160211311

Recall #: Z-1743-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96731
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: AVID Medical, Inc.
Manufactured In: United States
Units Affected: 3 products (72 units; 60 units; 72 units)
Distributed To: Illinois, Louisiana

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.