Recall of Medline Convenience Kits Due to Design Changes
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Medline Industries is recalling 270,311 units of convenience kits containing 10mL Polycarbonate Colored Syringes because of unapproved design changes.
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 "low" 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.
Recall of Medline Convenience Kits
What Happened
Medline Industries, LP is recalling certain convenience kits due to unapproved design changes to the products outside of the 510(k) clearance.
Which Products Are Affected
The affected products are Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, specifically E P DRAPE PACK-LF with code DYNJ0373061J. The UDI-DI is 10889942396856 (EA) and 40889942396857 (CS), with LOT 24ABR895. A total of 270,311 units are affected, distributed nationwide in the US and to the countries of Canada, Panama, and Barbados.
What You Should Do
Consumers who have these products should follow the initial firm notification, which was a letter, for instructions from Medline Industries, LP.
Why This Matters
This recall affects over 270,000 units of medical devices, potentially impacting product safety and compliance in healthcare settings.
Source
Attribution: FDA. For more information, refer to the FDA recall page for recall number Z-1889-2026.
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 (1,037 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.