Medline Convenience Kits Recall for Unapproved Design Changes
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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 initiated a voluntary recall after identifying unapproved design changes to the products outside of the 510(k) cleared by the FDA. The products were not initially reported in RES 98601. The recall is classified as Class II.
Which Products Are Affected
The recall affects Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes 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. Affected products include:
- ANGIOGRAPHY PACK-LF (DYNJ0854485S, UDI-DI 10193489250558, Lot 21BMA604)
- DEEP BRAIN STIMULATION PACK (DYNJ0842793G, UDI-DI 10195327293666, Lots 22LDA183, 23EDB049, 23HDC042, 23JDA988, 24DDA005)
- And additional packs: NEURO ACCESSORY PACK (DYNJ55385A), NEURO ANGIO PACK (multiple DYNJ SKUs), NEURO CERVICAL PACK, NEURO PACK, NEURO TRAY, NEURO VASCULAR PACK, NEURO VP SHUNT PACK-LF, NEUROLOGICAL CATH PACK, NEURORADIOLOGY PK, RADIOLOGY ANGIO MAJOR PACK-LF, RADIOLOGY NEURO DRAPE PAC, RRMC ANGIO PACK. Total: 113,843 kits. Full lot and UDI details are listed in FDA recall Z-2586-2026.
What You Should Do
Consumers should contact Medline Industries, LP for return or refund instructions. The firm initiated notification via letter.
Why This Matters
The recall involves medical device kits distributed across the United States and Barbados, addressing regulatory compliance issues with FDA-cleared designs.
Source
FDA recall number Z-2586-2026
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 (1,570 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.