Class II U.S. Food and Drug Administration

Fresenius Medical Care Holdings, Inc. Optiflux¿ High Flux E-beam Dialyzer Model recall: To provide further information to the user to ensure proper use

Recall published 1+ years ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0041-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Medical Care Holdings, Inc.
Product type
Medical devices
Units affected
172,494,732 units (14,374,561 cases @ 12 units per case)
Distribution
Nationwide
Made in
United States
Lot / code info
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;
UPC codes
840861100149, 840861100156, 840861100163, 840861100170

Products covered by this recall

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

Check your product

The notice names 16 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 840861100149
  • 840861100156
  • 840861100163
  • 840861100170

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • manufactured after SEP
  • 06
  • 2023

Model or item number

On the rating label, the box or the instruction sheet.

  • 0500316E OPTIFLUX F160NRe 12
  • CS 1.5SA EBEAM
  • UDI-DI
  • 0500318E OPTIFLUX F180NRe 12
  • CS 1.7SA EBEAM
  • 0500320E OPTIFLUX F200NRe 12
  • CS 1.9SA EBEAM
  • 0500325E OPTIFLUX F250NRe 12
  • CS 2.5SA EBEAM

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Fresenius Medical Care Holdings, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Fresenius Medical Care Holdings, Inc. — 920 Winter St Bld 920, Waltham, MA, 02451-1521

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Medical Care Holdings, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 840861100149, 840861100156, 840861100163; lot code manufactured after SEP, 06, 2023; model number 0500316E OPTIFLUX F160NRe 12, CS 1.5SA EBEAM, UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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