Z-0041-2026Class II

Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2)...

Name: Z-0041-2026 Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2)...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2025-08-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2025-08-29 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 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)... on 2025-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0041-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-29
Posted: 2025-10-03
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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
Product code: FJI Dialyzer, Capillary, Hollow Fiber
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.
Root cause tag: design
FDA root cause: Device Design
Action: On August 29, 2025 IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers. Actions to be taken: 1. Follow the New Instructions for Use provided in this letter when attaching the dialyzer caps. 2. Please report any complaints or adverse events to product.complaints@fmcna. com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safetyinformation/ medwatch-forms-fda-safety-reporting. 3. Please forward this notice to any providers who may have received these products from you. Place this notification with the device to ensure awareness. For product technical questions or concerns, please contact the Technical Support at 1- 800-323-2732 or Customer Support at 1-800-323-5188. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855- 616-2309. This notification serves as important medical device information. FMCRTG is not requesting the return of any product. FMCRTG is working diligently to provide the updated Instructions for Use with the product and expects release in Q4 2025. The health and safety of your patients continue to be our highest priority. Thank you for your cooperation.
Quantity in commerce: 172,494,732 units (14,374,561 cases @ 12 units per case)
Distribution: US Nationwide distribution.
Product codes and lots: 1. Model: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, UDI-DI: 840861100149, All Lots manufactured after SEP/06/2023, 2. Model: 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, UDI-DI: 840861100156, All Lots manufactured after SEP/06/2023, 3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, UDI-DI: 840861100163, All Lots manufactured after SEP/06/2023, 4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM, UDI-DI: 840861100170, All Lots manufactured after SEP/06/2023;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0041-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0041-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-03

Product code FJI

K162488Class IIOptiflux dialyzerFresenius Medical Care North America / cleared 2017-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)