Recall Z-2148-2026— Medline Industries, LP
Class I · Ongoing
Class I FDA medical device recall by Medline Industries, LP, initiated 2026-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-03-24
- Firm location
- Northfield, IL, United States
Product description
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Reason for recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Data sourced from openFDA. This site is unofficial and independent of the FDA.