Recall Z-0041-2026— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0041-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-29

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2025-08-29. It names one FDA 510(k) clearance: K162488. Product: Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM. Reason: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-29
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162488 — Optiflux dialyzerFresenius Medical Care North America·cleared 2017-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

Reason for recall

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

Data sourced from openFDA. This site is unofficial and independent of the FDA.