Brand Name: Fortress Introducer Sheath System Product Name: Fortress… — Class II medical device recall Z-2532-2025
Ongoing recall by Contract Medical International GmbH, reported 2025-09-17, distributed nationwide. Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device
| Recall number | Z-2532-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Contract Medical International GmbH, Dresden, N/A, Germany |
| Recall initiated | 2025-07-30 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, CH, CL, CZ, DE, DK, ES, FI, FR, GB, HR, HU, IE, IL, IT, KR, MY, PL, SE, SI, SK, TH, TW, VN |
| Quantity | 2,500 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04251244503703 |
| Lot numbers | 800989 |
| Model numbers | 386594 |
| Expiration dates | 2027-10-31 |
Product
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
Reason for recall
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
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-2532-2025. 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.