Recall of Medline Convenience Kits with 10mL Syringes Due to Unapproved Design Changes

Source: FDA · United States

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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.