Recall of Medline Convenience Kits with 10mL Syringes Due to 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 270,311 units of certain convenience kits because of unapproved design changes outside of 510(k) clearance, affecting products distributed nationwide in the US and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 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, cpsc, Devices.
Recall Article
What Happened
Medline Industries, LP is initiating a voluntary recall of certain convenience kits due to unapproved design changes to the products that were made outside of the 510(k) clearance.
Which Products Are Affected
The affected products are Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, specifically:
- GU DAVINCI PACK - LF with SKU DYNJ909398A
- ROBOTIC PACK with SKU DYNJ908706D The product quantity is 270,311 total units. UDI-DI codes are 10195327338190 (EA) and 40195327338191 (CS) for DYNJ909398A, with lots: 24GMH510 and 24HMG886. For DYNJ908706D, UDI-DI codes are 10198459017773 (EA) and 40198459017774 (CS), with lots: 24HMA783, 24HMG308, 24KMC651, 24KMJ274, 24LME931, 25AME217, and 25BMI653. Distribution includes US Nationwide and the countries of Canada, Panama, and Barbados.
What You Should Do
Consumers who have these products should follow the initial firm notification, which is a letter from Medline Industries, LP, for instructions on the recall.
Why This Matters
This recall addresses potential issues with medical devices not meeting approved standards, helping to maintain product safety and regulatory compliance in one sentence.
Source
FDA Recall Notice: Z-1885-2026. Attribution to FDA.
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 (1,298 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.