FDAClass I · Medical device · Recalled May 20, 2026
Namic Angiographic Manifold 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-2138-2026
- Brand
- Medline Industries
- Classification
- Class I
- Units affected
- 7075 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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
- UDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.
- 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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