Medline Industries Recalls Manifold Kits Due to Particulate (Z-2144-2026)
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FDA announces Class I recall of 322460 Medline manifold kits 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Which Products Are Affected
The recall affects 322460 kits distributed US (nationwide) and to AE, AU, CA, JP, KR, NL, SG, SK. Affected Medline Kit Numbers/SKUs include 60010195, 60033123, 60050183, 60080349, 60100338, 60101017, 60130506, 60131324, 60132238, 60138301, 60140589, 60192012, 60220488, 60232091, 65010037, 65012819, 65040421, 65183482, 65660872, 601006269, 601203616, 650104611, 651304116, 656206837, 656608724, 656608737, 656608739, 656608749, 656608753, 656608755, 6010236231, 6561068101, 60022681B, DYNJ0376288O, DYNJ0376288P, DYNJ04636M, DYNJ0771922AA, DYNJ0771922Y, DYNJ21810L, DYNJ21810M, DYNJ21810N, DYNJ22553F, DYNJ24250F, DYNJ27274J, DYNJ27274K, DYNJ27274L, DYNJ32376G, DYNJ32376I, DYNJ38087G, DYNJ38333C, DYNJ44473C, DYNJ44473D, DYNJ50779F, DYNJ51615N, DYNJ51615O, DYNJ51615Q, DYNJ53947I, DYNJ53947J, DYNJ57748B, DYNJ60584F, DYNJ60584G, DYNJ60584I, DYNJ61984B, DYNJ64525B, DYNJ64525C, DYNJ64548D, DYNJ64548F and additional SKUs listed in the recall notice. Specific lot numbers and UDI/DI codes are detailed in the FDA notice.
What You Should Do
No specific consumer instructions are provided in the recall notice.
Why This Matters
This is a Class I recall involving 322460 kits distributed nationwide.
Source
FDA recall number Z-2144-2026, event ID 98735. Recalling firm: Medline Industries, LP, Northfield, IL.
Original source: FDA Official Notice ↗
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