FDAClass I · Medical device · Recalled May 20, 2026

Medline medical convenience kits recall — Medline Industries, LP

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

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2148-2026
Brand: Medline Industries
Classification: Class I
Units affected: 107 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

Affected products

Medline medical convenience kits

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98735
Recall initiated: March 24, 2026
FDA classified: May 8, 2026
FDA report date: May 20, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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