Medline TAVI Medical Kits Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP is recalling 107 medical convenience kits containing Namic Manifolds labeled as TAVI 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 2, 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 has identified the presence of particulate within the fluid path of the Manifolds.
Which Products Are Affected
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C. Product quantity: 107 kits. UDI/DI each 10193489475135, UDI/DI case 40193489475136. Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624. Recall number Z-2148-2026. Distributed US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
What You Should Do
Check lot numbers against the affected list provided by the recalling firm.
Why This Matters
This is a Class I recall involving devices distributed nationwide.
Source
FDA recall Z-2148-2026, Medline Industries, LP
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 (747 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.