HIGH

Fresenius Medical Dialyzer Recalled Over Cap Attachment Issue

Fresenius Medical Care Holdings recalled over 172 million dialyzers on August 29, 2025. The recall affects models with a new cap design that may not securely attach. Healthcare providers and patients must stop using these devices immediately.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Fresenius Medical Care Holdings
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall includes four models of the Optiflux High Flux E-beam Dialyzer: 0500316E, 0500318E, 0500320E, and 0500325E. Each model is packaged in cases of 12 units, totaling 172,494,732 units distributed across the U.S. after September 6, 2023.

The Hazard

The dialyzers have undergone a design change, replacing threaded caps with press-on caps. Users may not properly secure the cap, leading to potential device malfunction during treatment.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. The high hazard level indicates a serious risk of improper device use.

What to Do

Patients and healthcare providers must stop using the affected dialyzers immediately. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for instructions and follow the recall guidelines.

Contact Information

For more information, visit the FDA website or contact Fresenius Medical Care Holdings, Inc. at the provided contact number.

Key Facts

  • Recall date: August 29, 2025
  • Distribution: U.S. nationwide
  • Total units recalled: 172,494,732
  • Models affected: Four specific Optiflux models
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeDialyzer
Sold At
Multiple Retailers

Product Details

Model Numbers
0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM
0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM
0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM
0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more