Namic Angiographic Manifold recall: Particulate Matter
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Why was Namic Angiographic Manifold recalled?
Medline has identified the presence of particulate within the fluid path of the Manifolds.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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,
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Recalling firm
- Medline Industries, LP
- Quantity
- 38175 units
- Distribution
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
- Recall date
- May 20, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)