Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Recall Summary Medline is recalling certain Namic Angiographic Manifolds and cardiopulmonary bypass adaptors, stopcocks, manifolds, and fittings because particles have been found in the fluid pathway of these medical devices. The recall affects products distributed nationwide across the US and in several other countries including Canada, Australia, Japan, and others. This is classified as a Class II recall, indicating a serious potential health risk.
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Reason
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/82529cb9-e873-4f53-84bd-d51d19373cdd