Recall Ledger

Medline medical convenience kits recall (Medline Industries, LP)

Medical deviceClass IOngoing

Summary: Medline Industries, LP is recalling Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.

What is being recalled

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Why

Medline has identified the presence of particulate within the fluid path of the Manifolds.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. (states named: California)

How to tell if yours is affected

UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2146-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedMarch 24, 2026
ReportedMay 20, 2026
CompanyMedline Industries, LP
Company locationNorthfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity0 kits

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Official FDA record