FreshRecalls

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-2143-2026
Brand
Medline Industries
Classification
Class I
Units affected
508 kits
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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.

Affected products

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
Medline Kit Number/SKU DYNJ23532C: UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number: 25DMA809; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23GBA252; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23HBI873; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23IBR043; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23KBF277; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 24ABQ959; Medline Kit Number/SKU VASC1057: UDI/DI each 10889942431922, UDI/DI case 40889942431923, Lot Number: 25KMF194.
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.

Report a data error on this page