Neurological Tray
Recall Summary Medline is recalling medical convenience kits (Medline Kit Number DYNJ904981C) containing Namic Manifolds labeled as TAVI because particles have been found in the fluid pathway of the manifolds. The recall affects kits distributed nationwide across the United States and in several other countries including Canada, Australia, Japan, and others. This is classified as a Class I recall, the most serious classification.
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
- Reason
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Classification
- Class I
- 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/ef437a03-0609-4bef-86f4-c3f1b3ae7f70