FDA Medical devices recall ·
PRISMAFLEX ST100 SET US, Product Code 107636US recall
- Recall number
- Z-1224-2026
- Date
- (initiated January 6, 2026)
- Company / brand
- Vantive Us Healthcare LLC
510 Lake Cook Rd, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 87,436 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Why was it recalled?
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00085412954073, All lots including and manufactured after 24G0072
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1224-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.