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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

Ivalon Surgical Wicks and Spears Recalled for Compromised Sterility

Agency Publication Date: January 2, 2025
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Summary

Carwild Corporation has recalled 560 units of Ivalon Eye Wicks, Cellulose Surgical Spears, and Anatomical Nasal Packing used during ophthalmic and nasal surgical procedures. These medical devices are being recalled because the package seals may be out of specification, which means the sterility of the products cannot be guaranteed for their intended shelf life. While no injuries or incidents have been reported, the company initiated this voluntary recall after identifying the potential for the sterile barrier to be compromised.

Risk

A compromised sterile barrier on surgical devices can lead to surgical site infections or other serious medical complications for patients undergoing eye or nasal surgeries.

What You Should Do

  1. This recall affects Ivalon Eye Wicks (Model Q604206, Lot 24G1880), Ivalon Cellulose Surgical Spears (Model Q604237, Lot 24G1739), and Ivalon Anatomical Nasal Packing with Airway Tube and String (Model Q770410, Lot 24F1638).
  2. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  3. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/return process

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

Affected Products

Product: Ivalon Eye Wick 20cm
Model / REF:
Q604206
Lot Numbers:
24G1880

Intended for the removal and collection of fluids from ophthalmic surgical sites.

Product: Ivalon CELLULOSE SURGICAL SPEAR
Model / REF:
Q604237
Lot Numbers:
24G1739

Intended for fluid management during ophthalmic surgical procedures.

Product: Ivalon Anatomical Nasal Packing with Airway Tube and String (8.0 cm x 1.5cm x 3.0 cm)
Model / REF:
Q770410
Lot Numbers:
24F1638

Intended for fluid management during ophthalmic surgical procedures.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95909
Status: Active
Manufacturer: Carwild Corporation
Sold By: Carwild Corporation; Medical distributors
Manufactured In: United States
Units Affected: 3 products (120 units; 300 units; 140 units)
Distributed To: Illinois, Florida, South Carolina, Pennsylvania, Alabama

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.