RegWardenFDA facility compliance records
Recall

Class II — New Medical Technologies Gmbh

Recalling firmNew Medical Technologies GmbH
Registered facilityNEW MEDICAL TECHNOLOGIES GMBH (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonDuring 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.
ProductIntegra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Quantity3,352 units (838 packs of 4)
DistributionWorldwide - 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.
Initiated2024-12-19
Classified2025-02-05
Recall numberZ-1104-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — New Medical Technologies Gmbh (Z-1104-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96067/

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