FDA Device recall Z-0801-2025
Dialyzer Optiflux 160NRe
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Dialyzer Optiflux 160NRe by Fresenius Medical Care Holdings, citing potential for internal blood leaks due to cracked polyurethane.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0801-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-05 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Dialyzer Optiflux 160NRe
Reason
Potential for internal blood leaks due to cracked polyurethane
Identifiers
| code_info | UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0801-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.