The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1103-2025·Announced 2025-02-12

Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening

Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a functional defect (premature valve opening) with no documented harm mechanism or actual injuries reported, warranting a Moderate severity score.

Plain-English summary

Integra Miltex CryoSolutions Cartridges (Model C-CA-23) containing 23.5g of nitrous oxide are being recalled due to a manufacturing defect. During assembly, the valve connecting the cartridge to its body part may open prematurely, resulting in partial or complete emptying of the cartridge before its intended use.

Approximately 430 units (43 packs of 10) were distributed nationwide to the following states: 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, and Canada.

Consumers who have purchased affected cartridges (Lot C6637) should stop using them and contact the manufacturer or their medical provider. The cartridges may not function as intended due to the defective valve.

The recalled product

Product
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Manufacturer
New Medical Technologies Gmbh
Category
Medical Device — Consumable Medical Supplies
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Model: C-CA-23
  • Item: 33516
  • UDI-DI: 10381780171959
  • Lots: C6637.

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 2 recalled by New Medical Technologies Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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