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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

Integra Miltex CryoSolutions Cartridges Recalled for Premature Emptying Risk

Agency Publication Date: February 5, 2025
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Summary

New Medical Technologies Gmbh has recalled approximately 3,782 Integra Miltex CryoSolutions Cartridges containing nitrous oxide. The recall affects cartridges sold in packs of 4 and 10, specifically model C-CA-23. The recall was initiated because the cartridge valve may open prematurely when being attached to its connecting body part, causing the cartridge to empty before it can be used for treatment. No injuries or incidents have been reported to date.

Risk

If the cartridge empties prematurely, it may result in a lack of available treatment gas during medical procedures. Additionally, the sudden release of pressurized gas during assembly could pose a minor physical risk to the user.

What You Should Do

  1. The recalled products are Integra Miltex CryoSolutions Cartridges (23.5g N2O each) sold in 4-packs and 10-packs under model number C-CA-23 with item numbers 33516 or 33517.
  2. Identify affected products by checking for lot numbers C6637, C6741, D0122, or D2560 printed on the packaging.
  3. Stop using the recalled device immediately to avoid potential treatment delays or unexpected gas release.
  4. Contact the manufacturer, New Medical Technologies Gmbh, or your authorized medical distributor to arrange for a return, replacement, or correction of the affected cartridges.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

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: Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each)
Variants: 10 Pack
Model / REF:
C-CA-23
33516
Lot Numbers:
C6637
UDI:
10381780171959

Quantity: 430 units (43 packs of 10)

Product: Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each)
Variants: 4 Pack
Model / REF:
C-CA-23
33517
Lot Numbers:
C6741
D0122
D2560
C6637
UDI:
10381780171966

Quantity: 3,352 units (838 packs of 4)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96067
Status: Active
Manufacturer: New Medical Technologies Gmbh
Sold By: Authorized medical distributors
Manufactured In: Switzerland
Units Affected: 2 products (430 units (43 packs of 10); 3,352 units (838 packs of 4))
Distributed To: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington

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.