FDA Medical devices recall ·
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2139-2026
- 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
- 38175 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812,
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-2139-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.