CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report

Integra Miltex Cryosolutions Cartridges N2O each) recalled

New Medical Technologies is recalling Integra Miltex Cryosolutions Cartridges N2O each), distributed nationwide in the US. The recall was initiated on 19 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: C-CA-23; Item: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637.

Quantity recalled3,352 units (838 packs of 4)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1104-2025
FDA event ID: 96067
Recalling firm: New Medical Technologies, Bern
Classification: Class II
Status: Ongoing
Recall initiated: 19 Dec 2024
FDA classified: 5 Feb 2025
Reported: 12 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Dec 2024	Recall initiated by company
5 Feb 2025	Classified by FDA	+48 days
12 Feb 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

Product as listed by the FDA

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

Where it was distributed

Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA and the country of Canada.

Nationwide Arkansas California Colorado Florida Georgia Illinois Indiana Kentucky Louisiana Massachusetts Maryland Minnesota Missouri North Carolina Nebraska New Jersey Nevada New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

Which lots are affected?

Model: C-CA-23; Item: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637.

Where was it sold?

Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96067

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025	CLASS II	Integra Miltex CryoSolutions Cartridges N2O each) recalled	New Medical Technologies	Other	Nationwide

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Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS II	Integra Miltex CryoSolutions Cartridges N2O each) recalled	New Medical Technologies	Other	Nationwide

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