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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

Carefree Surgical Specialties Kittner Roll Gauze Recalled for Contamination

Agency Publication Date: August 8, 2025
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Summary

Carefree Surgical Specialties is recalling 1,085 units of Robotic/Laparoscopy Kittner Roll Gauze because the sterile packaging may contain biological foreign matter or incorrect quantities of gauze. The recall includes Large and Medium sized gauze rolls and those with "Tail" features. While no injuries have been reported, using contaminated surgical materials can pose serious health risks to patients.

Risk

The presence of biological foreign matter compromises the sterility of the surgical gauze, which can lead to infections or other complications if used during surgery. Additionally, incorrect gauze counts in packaging can lead to errors during surgical protocols and procedures.

What You Should Do

  1. This recall affects Carefree Surgical Specialties Robotic/Laparoscopy Kittner Roll Gauze, including models with and without "Tails" in Large and Medium sizes.
  2. Identify if you have affected products by checking for model numbers 15508/25, 15505/25, or 15506/25 and lot numbers 1595, 1645, 1650, or 1607.
  3. Stop using the recalled device immediately. Contact the manufacturer, Carefree Surgical Specialties, or your distributor to arrange for a return, replacement, or correction of the affected units.
  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: Robotic/Laparoscopy Kittner + Tail Large 4" Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Variants: Large, 5pk, 25pk/CS
Model / REF:
15508/25
Lot Numbers:
1595

Recall #: Z-2281-2025

Product: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4" Long X-Ray Detectable 5/pk 25pk/CS
Variants: Medium, 5/pk, 25pk/CS
Model / REF:
15505/25
Lot Numbers:
1645
1650

Recall #: Z-2282-2025, Z-2283-2025

Product: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4" Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Variants: Medium, 5pk, 25pk/CS
Model / REF:
15506/25
Lot Numbers:
1607

Recall #: Z-2284-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97259
Status: Active
Manufacturer: Carefree Surgical Specialties
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 4 products (20; 500; 500; 65)
Distributed To: Kentucky, Texas, Florida, North Carolina, Colorado, California, Idaho, West Virginia, New York, Illinois, Indiana, Iowa, Michigan, Louisiana, Wisconsin, Montana, Virginia, Massachusetts, Tennessee, Connecticut, Alabama, Pennsylvania, Missouri, New Jersey, Arkansas, Ohio, Nebraska, Arizona, Minnesota, Maryland, Georgia, Washington, Vermont, Oklahoma, Rhode Island, South Carolina, New Hampshire, Nevada, Oregon

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.