Device recall: PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Class II FDA enforcement event 98180. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
VANTIVE US HEALTHCARE LLC started this device recall on 6 Jan 2026. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 98180 has 8 product records. The first FDA enforcement report date is 11 Feb 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution.
Recalling firm
VANTIVE US HEALTHCARE LLC, Deerfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1224-2026 | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 87,436 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1225-2026 | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 264,040 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1226-2026 | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2,724 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1227-2026 | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 230,596 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1228-2026 | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 137,576 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1229-2026 | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 93,576 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1230-2026 | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 115,112 units | Class II | Ongoing | 11 Feb 2026 |
| Z-1231-2026 | PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System | 13,760 units | Class II | Ongoing | 11 Feb 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 8Median of the firm: 3
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Aug 2025 | Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8 | Device | Class II | 1 |
| 28 Jul 2025 | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-1224-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98180. https://recallregister.com/fda/ii/98180/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution.
- What quantity of product is in FDA event 98180?
- The event has 8 product records. The first record gives this quantity:
87,436 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.