Medline Convenience Kits Recall for Unapproved Syringe Design
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 distributed nationwide 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
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Which Products Are Affected
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. Affected kits include: AAA DYNJ905651B ARTERIOGRAM TRAY (UDI-DI 10193489925067, Lot 24BME750), 00-402001S AV SHUNT PACK-LF (UDI-DI 10889942893645, Lots 21ABV063, 21BBK296, 21OBA437), DYNJ0842516F BASIC IR PACK-LF (UDI-DI 10193489352375, multiple lots), PHS463660F CATH PROCEDURAL TRAY (UDI-DI 10195327096991, Lots 22BBT652, 22DBK236), and additional kits including DYNJ43580C, DYNDA2213A, DYNJ65277A, DYNJ0842793F, DYNJ67918, DYNJ56666B, DYNJ44123A, DYNJ51126B, PAIN1454, DYNJ905160I, DYNJ0843063J, DYNJ37304F, DYNJ56386B, DYNJ907758, DYNJ40952, DYNJ60715, DYNJ37484B, DYNJ908706A, DYNJ0101339J, DYNJ69090, DYNJ56260B with listed UDI-DIs and lot numbers. Total: 113,843 kits. Distributed nationwide in the US 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 Barbados.
What You Should Do
The recall was initiated voluntarily by the firm via letter. No additional consumer instructions are provided in the recall data.
Why This Matters
The Class II recall affects 113,843 kits distributed across the United States and Barbados.
Source
FDA Enforcement Report, recall number Z-2585-2026, 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 (1,486 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.