Medline Convenience Kits Recall Over 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, medical-devices.
What Happened
Medline Industries, LP initiated a voluntary recall of convenience kits after identifying unapproved design changes to the products outside of the 510(k) cleared by the FDA. The recall is classified as Class II and affects products not initially reported in RES 98601.
Which Products Are Affected
The recall involves Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes 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 Barbados. Affected products include:
- ANGIO PACK: DYNJ30565C (UDI-DI 10889942165704, Lots 21CDA555, 21DDA970), DYNJ32555B (UDI-DI 10884389648216, Lot 21AMA053)
- ANGIO PACK-LF: DYNJ0774765U (UDI-DI 10193489634594, Lot 21FLA468)
- ANGIO TRAY: DYNJ46153A (UDI-DI 10889942185863, Lots 20XBH471, 21BBC325)
- ANGIOGRAM TRAY: DYNJ33638K (UDI-DI 10193489343281, Lot 21HLA726)
- ANGIOGRAPHY DRAPE PK QVH-LF: DYNJ35110D (UDI-DI 10193489329940, Lot 21IMC537)
- ANGIOGRAPHY PACK: DYNJ44293D (UDI-DI 10193489833416, Lots 21CBE250, 21CBX084, 21FBB546, 21HBD075, 21KBN509, 22ABV463, 22BBX022, 22DBJ641, 22HBB710, 22HBT960, 22IBD236, 22OBF392)
- ANGIOGRAPHY PACK-LF: DYNJ0854485T (UDI-DI 10193489864199, Lots 21FBC416, 21GBL506, 21IBO920, 21JBS587)
- GENERAL ANGIO PACK: DYNJ35916J (UDI-DI 10193489838404, Lots 21CBF463, 21DBP668, 21DBR247), DYNJ57760B (UDI-DI 10193489342581, Lots 21CME104, 21EME408, 21FMD506, 21GMG028, 21JMF774, 21KMH487)
- GENERAL ENDO PACK-LF: DYNJ0842873J (UDI-DI 10193489448917, Lots 21ADA204, 21CDB566, 21EDB709, 21GDC532, 21HDC041, 21JDB401, 21JDC566, 21LDA726, 22BDA893, 22CDC138, 22EDA075, 22FDC040, 22HDB149, 22JDA080)
- JUDKINS PACK: DYNJ51126A (UDI-DI 10193489854886, Lots 21DDA694, 21EDB249, 21GDD164, 21IDA472, 21KDA815)
- RADIOLOGY ANGIO MAJOR PACK: DYNJ62858B (UDI-DI 10193489891263, Lots 21FMF601, 21HMF637, 21HMG835, 21JMF531)
- TAVR JUDKINS PACK: DYNJ51127B (UDI-DI 10193489854893, Lot 22FBV791) Recall number: Z-2591-2026. Total units: 113,843 kits.
What You Should Do
Consumers should contact Medline Industries, LP for return or refund instructions. The recalling firm is located at 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
The recall addresses regulatory compliance issues with medical device kits used in angiographic and related procedures distributed across the United States and Barbados.
Source
FDA Recall Z-2591-2026 - Medline Industries, LP
Original source: FDA Official Notice ↗
Related FDA Recalls
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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
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Similar severity timing
Same severity (medium) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
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