FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline medical convenience kits with Namic Manifold recalled for particulate contamination
What this means
Medline identified particles inside the fluid pathways of Namic Manifolds used in three medical convenience kits: Angiography Cath Lab, Cath Lab Pack, and Angio Kit. These particles could potentially affect the performance of the manifold during use. Approximately 508 kits have been distributed across the U.S. and several other countries.
- Check if your facility has any of the affected kit numbers: DYNJ23532C, DYNJ65185, or VASC1057.
- Review the lot numbers provided by Medline to identify affected inventory.
- Contact Medline immediately if you have affected kits to discuss appropriate actions.
- Do not use affected kits until you have confirmed they are safe or received replacement instructions from Medline.
The agency's original wording
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Intended for
Adults
Illnesses reported
None reported
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
508 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2026More Medline recalls
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- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
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