Fresenius Medical Care Holdings, Inc.: Device Recall

Recall Details

Recall Number

Z-0041-2026

Classification

Class II

Product Type

Device

Recalling Firm

Fresenius Medical Care Holdings, Inc.

Status

Ongoing

Date Initiated

08/29/2025

Location

Waltham, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

172,494,732 units (14,374,561 cases @ 12 units per case)

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.

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

Distribution Pattern

US Nationwide distribution.

Other Recalls by Fresenius Medical Care Holdings, Inc.

• Class II: Risk 10/25/2025
  Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
• Class II: Risk 05/27/2025
  Lack of Assurance of Sterility
• Class II: Risk 04/29/2025
  Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
• Class II: Risk 12/05/2024
  Potential for internal blood leaks due to cracked polyurethane
• Class II: Risk 08/08/2024
  Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

View all recalls by Fresenius Medical Care Holdings, Inc. →