Integra Miltex Cryosolutions Cartridges 4 Pack — Class II medical device recall Z-1104-2025
Ongoing recall by New Medical Technologies Gmbh, reported 2025-02-12, distributed nationwide. During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in
| Recall number | Z-1104-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Medical Technologies Gmbh, Bern, Switzerland |
| Recall initiated | 2024-12-19 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 10381780171966 |
| Lot numbers | C6637, C6741, D0122, D2560 |
| Model numbers | 33517, C-CA-23 |
Product
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1104-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.