CLASS I ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Medline medical convenience kits, containing Namic Manifold recalled
Medline Industries is recalling Medline medical convenience kits, containing Namic Manifold, Labeled as: Angiography Cath, distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2143-2026
- FDA event ID
- 98735
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Mar 2026
- FDA classified
- 8 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 24 Mar 2026 | Recall initiated by company | |
| 8 May 2026 | Classified by FDA | +45 days |
| 20 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Product as listed by the FDA
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.
Where it was distributed
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Questions about this recall
Why was it recalled?
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Which lots are affected?
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.
Where was it sold?
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 98735This product is part of a recall event; the main page for the event is Medline medical convenience kits, containing Namic Manifold recalled.
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