FDA Medical devices recall ·
Medline medical convenience kits, containing Namic Manifold… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2148-2026
- Date
- (initiated March 24, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 107 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Why was it recalled?
Medline has identified the presence of particulate within the fluid path of the Manifolds.
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 each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
States: California
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2148-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.