This is part of a larger recall. The most authoritative record is FDA-Device / Z-2144-2026.
FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline HEART CATH PACK-LF medical kits recalled for particulate contamination in fluid path
OTHERNationwide distribution
Medline HEART CATH PACK-LF kits recalled for particulate contamination
Medline identified particles inside the fluid pathway of Namic Manifolds used in HEART CATH PACK-LF medical convenience kits. These particles could potentially interfere with the safe operation of the device during cardiac catheterization procedures.
- If you have a HEART CATH PACK-LF kit with Lot Number 26CMC977, stop using it immediately
- Contact Medline or your healthcare facility for instructions on returning or replacing affected kits
- Check your facility's inventory using the UDI/DI numbers 10889942814619 (individual) or 40889942814610 (case)
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
0 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2026More Medline Industries, LP recalls
- FDA-Device2026-07-01Medline surgical convenience kits recalled for unapproved syringe design changes
- FDA-Device2026-07-01Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62
- FDA-Device2026-07-01Medline surgical convenience kits with syringes recalled for unapproved design changes
- FDA-Device2026-07-01Medline medical convenience kits with syringes recalled for unapproved design changes
- FDA-Device2026-07-01Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief