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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fresenius Medical Care Holdings
- Product type
- Dialyzer
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Optiflux High Flux E-beam Dialyzers are used in hemodialysis to remove waste products from the blood. They are sold to healthcare providers and facilities for patient treatment.
Why This Is Dangerous
The recall centers on a cap design issue. A shift from threaded to press-on caps requires firm pressing to secure. If not secured properly, there could be device integrity concerns.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
The recall affects a large stock likely used in dialysis centers. The immediate impact is operational shutdown of affected devices until replacement guidance is provided.
Practical Guidance
How to identify if yours is affected
- Inspect cap type: threaded vs press-on; press-on caps must be firmly attached.
- If you own or operate an affected dialyzer, stop using it immediately and contact the manufacturer.
Where to find product info
Refer to the FDA recall page and Fresenius Medical Care’s recall communications for model-specific guidance.
What timeline to expect
Replacement or refund options are processed after manufacturer instructions are issued. Typical timelines range from several weeks to a couple of aix.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Consult your healthcare provider for interim guidance and potential alternatives.
How to prevent similar issues
- Verify cap compatibility before use.
- Follow manufacturer-provided procedures for cap attachment.
- Ask distributors for recall status before stocking devices.
Documentation advice
Keep the recall letter, model numbers, purchase documentation, and all correspondence with the manufacturer and healthcare providers.
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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. Distribution: US nationwide. Quantity: 172,494,732 units (14,374,561 cases @ 12 units per case). Recall date: 2025-08-29. Recall status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 172,494,732 total units recalled
- 4 model numbers affected
- Caps changed to press-on design requiring firm engagement
- US nationwide distribution
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Safety Guide
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