Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0801-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Dialyzer Optiflux 160NRe

Product Classification:

Class II

Date Initiated: December 5, 2024

Date Posted: January 15, 2025

Recall Number: Z-0801-2025

Event ID: 95884

Reason for Recall:

Potential for internal blood leaks due to cracked polyurethane

Status: Ongoing

Product Quantity: 5,351 cases (64,212 dialyzers)

Code Information:

UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated