Dialyzer Optiflux 160NRe — Class II medical device recall Z-0801-2025
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2025-01-15, distributed nationwide. Potential for internal blood leaks due to cracked polyurethane
| Recall number | Z-0801-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2024-12-05 |
| Classified | 2025-01-03 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Expiration dates | 2027-06-30 |
Product
Dialyzer Optiflux 160NRe
Reason for recall
Potential for internal blood leaks due to cracked polyurethane
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-0801-2025. 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.