Medline Namic Angiographic Manifold Recall Issued
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Medline Industries, LP is recalling 38,175 units of Namic Angiographic Manifolds due to particulate in the fluid path.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP has initiated a recall of certain Namic Angiographic Manifolds after identifying the presence of particulate within the fluid path.
Which Products Are Affected
The recall covers Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301 (also described as Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting). A total of 38,175 units are affected. Affected lot numbers include: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812. UDI/DI: each 10193489059168, case 30193489059162. The recall number is Z-2139-2026. Distribution was nationwide in the US and to AE, AU, CA, JP, KR, NL, SG, SK.
What You Should Do
Consumers and facilities should follow instructions provided by Medline Industries, LP regarding the recalled products.
Why This Matters
This Class I recall involves devices distributed across the United States and internationally.
Source
FDA recall Z-2139-2026, Medline Industries, LP, Northfield, IL.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,095 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.