FDA Recall of Medline Convenience Kits Due to Unapproved Design Changes
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Medline Industries is recalling 270,311 units of specific convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes outside of 510(k) clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. 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.
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, cpsc, Devices.
What Happened
Medline Industries, LP is conducting a voluntary recall of certain convenience kits due to unapproved design changes to the products that were made outside of the 510(k) clearance.
Which Products Are Affected
The affected products include Medline Convenience Kits with the following SKUs: BIOPSY PACK (DYNJ38587A and DYNJ38587B), BIOPSY/DRAINAGE TRAY-LF (DYNJ30078D), and W LINQ PACK (DYNJ59108B). The total quantity affected is 270,311 units. Specific code information includes: For DYNJ38587A, UDI-DI 10193489754070 (EA) and 40193489754071 (CS) with lots such as 20BBF696, 20EBH917; for DYNJ38587B, UDI-DI 10195327397326 (EA) and 40195327397327 (CS) with lots like 23DBP789; for DYNJ30078D, UDI-DI 10889942138647 (EA) and 40889942138648 (CS) with lots including 23CBK546; and for DYNJ59108B, UDI-DI 10198459138461 (EA) and 40198459138462 (CS) with lot 24JBP861. The distribution is nationwide in the US and also includes Canada, Panama, and Barbados.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Medline Industries, LP, for further instructions regarding the recall.
Why This Matters
This recall affects over 270,000 units of medical devices, highlighting potential risks from unapproved changes that could impact product safety and compliance in healthcare settings.
Source
FDA recall notice Z-1879-2026, attributed to the U.S. Food and Drug Administration (FDA).
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 (1,489 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.