Z-2139-2026 Class I Ongoing
FDA device recall Z-2139-2026 was initiated by Medline Industries, LP on March 24, 2026 and is designated Class I. Reason for recall: Medline has identified the presence of particulate within the fluid path of the Manifolds. The recall status is ongoing. Affected quantity: 38175 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- March 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38175 units
Product Description
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Reason for Recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Distribution Pattern
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Code Information
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,