Medline Convenience Kits Recall
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Medline Industries, LP is recalling 270,311 units of various convenience kits containing 10mL polycarbonate colored syringes due to 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 7, 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, fda, Devices.
Medline Convenience Kits Recall
What Happened
Medline Industries, LP is recalling certain convenience kits containing select SKUs of 10mL polycarbonate colored syringes because of unapproved design changes to the products outside of the 510(k) clearance.
Which Products Are Affected
The affected products include the following Medline Convenience Kits with specific SKUs: ANGIO KIT PACK (DYNJ50783B), ANGIO PHC (DYNJ37485C), C.I.C.N. ANGIO PACK (DYNJ53064B), FHT P NEURO PACK (DYNJ39931D), NEURO ARTERIOGRAM PACK-LF (DYNJ0948060F), NEURO KIT (NAM0003), NEURO PACK (DYNJ61542D), NEURO RADIOLOGY PACK (DYNJ59903B), NEURO TRAY (DYNJ84872A), PK, CATH LAB-ANGIO (DYNJ44027F), and QVH IR NEURO PACK (DYNJ62176). The total quantity affected is 270,311 units. Specific lots and UDI-DIs are provided in the recall details, such as DYNJ50783B with UDI-DI 10193489227376 (EA) and lot 23FBF183. Distribution occurred nationwide in the United States and internationally to countries including Canada, Panama, and Barbados. The recall number is Z-1884-2026.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact Medline Industries, LP for instructions on the recall, including returns or refunds.
Why This Matters
This recall involves over 270,000 units of medical devices, emphasizing the need for regulatory compliance to prevent potential health risks from unapproved changes. It affects distribution in the United States and several other countries, highlighting the global scope of product safety issues.
Source
Attribution: FDA recall database. For more information, refer to FDA recall number Z-1884-2026.
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 (1,681 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.