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 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. This is an ongoing Class II recall.
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:
- CRANIOTOMY PACK-LF: DYNJ0101292F, DYNJ0101292G
- HYBRID PACK: DYNJ65925A
- LAMINECTOMY: DYNJ905156L, DYNJ905156M, DYNJ905156N, DYNJ905156O, DYNJ905156P
- MAJOR EXTREMITY: DYNJ905159F, DYNJ905159I, DYNJ905159J, DYNJ905159K
- NEURO CERVICAL PACK: DYNJ0101287J, DYNJ0101287K
- NEURO SPINE PACK: DYNJ81612C
- POSTERIOR SPINE PACK-LF: DYNJ0843339L, DYNJ0843339M, DYNJ0843339N
- SPINE PACK: DYNJ30150F
113,843 kits are affected. Specific UDI-DI and lot numbers are listed in the recall notice.
What You Should Do
Consumers should follow instructions provided by the recalling firm regarding the affected kits.
Why This Matters
The recall involves over 113,000 medical procedure kits distributed across the United States and Barbados that do not comply with the FDA-cleared design.
Source
https://www.fda.gov - FDA Recall Number Z-2587-2026, 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 (1,500 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.