FDA recall, , Moderate risk
Vantive Prismaflex and Oxiris Dialyzer Sets
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Summary by Recall Canary from the FDA notice
What happened
VANTIVE US HEALTHCARE LLC, of Deerfield, Illinois, is voluntarily recalling certain Prismaflex and Oxiris sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
The recall involves the Prismaflex M100, M150, ST100 Set US, TPE2000, HF1000, and ST150 Set US, as well as the Oxiris Set, all classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System. The recall was initiated on January 6, 2026, and was added to the FDA's Enforcement Report on February 2, 2026.
The products were distributed nationwide in the United States. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
8 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Oxiris Set, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 07332414102234
- Lot code
- All lots including and manufactured after 24G0041Z
Primsaflex M100 Set, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 07332414064556
- Lot code
- All lots including and manufactured after 24F0077CA
Prismaflex M150 Set, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 07332414090005
- Lot code
- All lots including and manufactured after 24F0100CA
Prismaflex ST100 Set US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 00085412954073
- Lot code
- All lots including and manufactured after 24G0072
Prismaflex TPE2000 Set, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 07332414111038
- Lot code
- All lots including and manufactured after 24J0106
Prismaflex HF1000 Set, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 07332414069254
- Lot code
- All lots including and manufactured after 24G0034CA
Prismaflex ST150 Set US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 00085412917696
- Lot code
- All lots including and manufactured after 24F0085
Prismaflex HF1000 Set, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- UDI-DI
- 07332414069315
- Lot code
- All lots including and manufactured after 24F0094CA
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Feb 2, 2026
- Sold in
US Nationwide distribution.
- Recalled by
- VANTIVE US HEALTHCARE LLCDeerfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 98180
- Recall numbers
- Z-1224-2026 to Z-1231-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from VANTIVE US HEALTHCARE LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
VANTIVE US HEALTHCARE began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
