Medline Convenience Kits Recall for Unapproved Design Changes
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP is recalling 113,843 convenience kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes outside the FDA-cleared 510(k).
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 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.
What Happened
Medline Industries, LP identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. The recall is classified as Class II and is voluntary, firm-initiated.
Which Products Are Affected
The recall affects convenience kits with the following SKUs and lots:
- CATARACT FULL BODY (DYNJ85743, UDI-DI 10195327542337, Lots 24ABP082, 24BBA479)
- MAJOR VASCULAR PACK (DYNJ81610C, UDI-DI 10195327556938, Lot 24BBB405)
- MINIMALLY INVASIVE PACK-LF (DYNJ0843063L, UDI-DI 10195327567071, Lots 23LDB992, 24BDA641, 24BDA782, 24FDA795, 24GDB014, 24HDB074)
- PEDIATRIC CATH ANGIO PACK (DYNJ54755J, UDI-DI 10195327549909, Lots 24ABJ741, 24CBI600, 24EBA488, 24FBM084, 24GBN355, 24HBH571)
- PERIPHERAL ARTERIOGRAM RAD (DYNJ61383C, UDI-DI 10195327593346, Lot 24CLA801)
- POSTERIOR SPINE PACK-LF (DYNJ0843339O, UDI-DI 10195327567057, Lots 24CDB480, 24DDA248, 24GDB068)
- UPPER EXTREMITY (DYNJ61907A, UDI-DI 10195327542450, Lot 24ABP069)
- VISCERAL ANGIOGRAM PACK-LF (DYNJ0429121L, UDI-DI 10195327587697, Lot 24BMH315)
113,843 kits were distributed nationwide in the United States, including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY, and to Barbados. Recall number Z-2590-2026.
What You Should Do
No specific consumer action steps are provided in the recall data.
Why This Matters
The recall involves over 113,000 medical device kits distributed across the United States and Barbados.
Source
FDA recall number Z-2590-2026, event ID 99062.
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 (1,575 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.