Medline Industries Recalls Medical Procedure Kits Due to Catheter Issues
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Medline Industries, LP is recalling 123,030 units of various medical procedure kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy and others because representative samples did not meet performance specifications for catheters.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references Worldwide. Its severity classification of "medium" 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.
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What Happened
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Which Products Are Affected
The recall covers MEDLINE Medical Procedure Kits (see the recall documents for a full list of products) with various Kit Numbers/SKUs including BIOB686, DYNJ83242, DYNJ83242A, DYNJ83242C, DYNJ67486A, DYNJ14052D, DYNJ14052F, DYNJ14053D, DYNJ14053F, DYNJ14053G, DYNJ22034L, DYNJ22034M, DYNJ89738, DYNJ89780, CDS982277M, DYNJ0785858I, DYNJ67331D, DYNJ67331F, DYNJ67331G, DYNJ67331I, DYNJ68302B, DYNJ68302A, DYNJ84442, DYNJ84442A, BIOB710, DYNJ80228, DYNJ80228A, DYNJ87820, DYNJT3892, DYNJ86144A, DYNJ86144B, DYNJ42921I, DYNJ81369, DYNJ81369A, DYNJ81542B, DYNJ902241I, DYNJ50874B, DYNJ0271168Q, DYNJ0271168R, DYNJ0271168S, CDS983654L, CDS983654M, DYNJ20266J, DYNJ87670, DYNJ903469J, DYNJ51846G, DYNJ908483, DYNJ36290G, DYNJ52874B, DYNJ64625B, DYNDA2133, DYNJ50571, DYNJ89713, DYNJ44041, DYNJ31204C, DYNJ908879G, DYNJ89521, DYNJ31816C, DYNJ38052D, DYNJ38052I, DYNJ38052J, DYNJT5319, DYNJ51750B, CDS983579I, CDS983911K, CDS982696K, DYNJ906921A, DYNJ940727F, DYNJ68808A, DYNJ61195, DYNJ80609F, DYNJ902028D, DYNJ55243B, DYNJ905339D, DYNJ900953A, DYNJ37192F, DYNJ43282I, DYNJ88736, DYNJ53927K, DYNJ53927L, DYNJ53927M, DYNJ53927N, DYNJ82134, DYNJ64324, DYNJ00091I, DYNJ60819I, DYNJ60819J, DYNJ60819L, DYNJ86081, DYNJ86081A, DYNJ60618G, DYNJT7060, DYNJ909130G, DYNJ907407C, DYNJ34550A, DYNJ58692, DYNJT5963, DYNJ85418, DYNJ905208C, DYNJ0541930O, DYNJ0541930P, DYNJ0541930Q, DYNJ31788L, DYNJ86210, DYNJ86210A, DYNJ87331, DYNJ87331A, DYNJ87331B, DYNJ69324C, DYNJ907498, DYNJV0260K, DYNJ902996G, DYNJ83288F, DYNJ905855, DYNJ908603D, DYNJ910501, DYKMBNDL117B, DYNJ902014D, DYNJ900358L, DYNJ901279D, DYNJ907168A, DYNJ907168B, DYNJ907168C, DYNJ908066, DYNJ908066A, DYNJ910155, DYNJ910842, DYNJ44028A, DYNJ51092, DYNJ51092A, DYNJ56187, DYNJ61951A, DYNJ61951B, DYNJ65334A, DYNJ69550, DYNJ69550A, DYNJ82116, DYNJ84870, DYNJ908888, DYNJ908888A, DYNJ908888C, DYNJ908888F, DYNJ908888G, DYNJ43053D, DYNJ87009, DYNJ87009B, DYNJ902174C, DYNJ902174I, DYNJ902165D, DYNJ905472F, CDS981542F, CDS983047J, CDS983047K, DYNJ81610C, DYNJ909656, DYNJ909656B, DYNJ909656C, DYNJ909735, DYNDA1487A, DYNJ58703B, CDS981789F, CDS984284G, DYNJ38248C, DYNJ38248D, DYNJ50753, DYNJ69788, DYNJ69788A, DYNJ69788B, DYNJ909739A, DYNJ48310F, DYNJ48310G, DYNJ48310I, DYNJ48310J, DYNJ82133, DYKM1227, DYNJ86645, DYNJ86645A, DYNJ14099I, DYNJ902258F, DYNJ80520B, DYNJ903010R, DYNJ903245C, DYNJ81096B, DYNJ911245, DYNJ89549A, DYNJ85781, DYNJ85781A, DYNJ911274A, DYNJ65954C, DYNJ32033O, DYNJ904645K, DYNJ0271227Q, DYNJ0271227R, DYNJ0374087Q, DYNJ0374087R, DYNJ0374087S, DYNJ04649N, DYNJ04649O, DYNJ50478G, DYNJ51443K, DYNJ56513F, DYNJ67179B, DYNJ67179C, DYNJ67179D, DYNJ81541B, DYNJ81541C, DYNJT7319, DYNJ04584L, DYNJ53984G, DYNJ53984I, DYNJ46411I, DYNJ37212K, DYNJ40210V, DYNJ80229, DYNJ37329A, DYNJT3168A, DYNJ905456A, DYNJ56963A, DYNJ60583A, DYNJ60583B, DYNJ60898C, DYNJ60898D, DYNJ60548D, DYNJ60548F, DYNJ81656A, DYNJ908046, DYNJ902183J, DYNJ902191F, DYNJ902191J, DYNJ902191K, DYNJ0394847P, DYNJ63390A, DYNJ63397, DYNJ66263D, DYNJ0394853L, DYNJ27134J, DYNJ25764J, DYNJ43861G, DYNJ22971V, DYNJ22971W, DYNJ900317C, DYNJ903254A, DYNJ906067I, DYNJ66114, DYNJ06974F, DYNJ25895C, DYNJ30258J, DYNJ35804A, DYNJ37369A, DYNJ38978B, DYNJ39203A, DYNJ39681, DYNJ43164, DYNJ50690C, DYNJ51203B, DYNJ53647A, DYNJ60727, DYNJ61297, DYNJ61472, DYNJ41981B, DYNJ53547A, DYNJ58464, DYNJ61009, DYNJ80620C, DYNJ84529B, DYNJ901375C, DYNJ911142, DYNJ30232M, DYNJ31670B, DYNJ36434A, DYNJ37266F, DYNJ41038G, DYNJ45343B, DYNJ46543O, DYNJ46543P, DYNJ47285C, DYNJ50346C, DYNJ52188B, DYNJ39484B, DYNJ47941C, DYNJ903470F, DYNJ903470G, DYNJ0488631I, DYNJ0488631J, DYNJ0488631K, DYNJ0488631L, DYNJ0488631N, DYNJ0488631O, DYNJ64323, DYNJ40163C, DYNJ40163F, DYNJ44349G, DYNJ60067, DYNJ65279A, DYNJ65279B, DYNJ88507, DYNJ10124D, DYNJ10127C, DYKM1138, DYNJ908978A, DYNJ908978C, DYNJ38054I, DYNJ38054J, CDS981551C, CVT060W, DYNJ56838G, DYNJ56838I, DYNJ82016A, DYNJVB1080B, DYNJ901279F, DYNJ901279G, DYNJ69742D. Specific UDI/DI and lot numbers are listed in the recall documents. The recall number is Z-2497-2026. 123,030 units are affected with worldwide distribution including US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
What You Should Do
Medline notified customers via email, fax, letter, press release, telephone, and visit. Consumers should refer to the recall documents or contact the recalling firm for return or correction instructions.
Why This Matters
This Class II recall involves devices that may cause temporary or medically reversible adverse health consequences.
Source
FDA Recall Z-2497-2026 - Medline Industries, LP, Northfield, IL
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
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Similar severity timing
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Frequently Asked Questions
Common questions about this FDA recall.