Medline Medical Kits Recall Over Syringe Connection Risk

Source: FDA · United States

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Medline Industries is recalling 439 medical convenience kits due to a potential risk of syringe disconnection during use, 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 April 23, 2026 and geographically references United States. Its severity classification of "high" 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 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.

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Medline Medical Kits Recall

What Happened

Medline Industries, LP is recalling certain medical convenience kits because of a potential risk that the syringe rotating adaptor may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold.

Which Products Are Affected

The recall involves the following products: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J. A total of 439 kits are affected. Specific lot numbers for DYNJ60803J include: 26BMA268, 26AMH928, 25EMD876, 25EMA519, 25DMA846, 25BMH004, 25BMA218, 24KMI208, 24KMC007, 24JMD850, 24IMI939, 24EDB694, 24DDB793, 24CDB207, 24BDB439, 23GDB756, and 23GDA532. For DYNJ58475F, the lot number is 25LMK173. The products have UDI/DI codes: for DYNJ58475F, each 10198459572388 and case 40198459572389; for DYNJ60803J, each 10195327138820 and case 40195327138821. Distribution was nationwide in the United States, including Puerto Rico, and to foreign countries such as Canada, Netherlands, Australia, Korea, Sri Lanka, Pakistan, Japan, United Arab Emirates, Singapore, and Slovakia. The official recall number is Z-1728-2026.

What You Should Do

Consumers should immediately stop using the affected products and contact Medline Industries, LP for instructions on returns or refunds. The firm is located at 3 Lakes Dr, Northfield, IL 60093-2753, and notifications were made via email, fax, letter, press release, telephone, or visit.

Why This Matters

This recall addresses a Class I issue, indicating a reasonable probability of serious adverse health consequences from the defect. It impacts medical devices used in procedures, emphasizing the need for reliable equipment in healthcare settings.

Source

This recall information is from the FDA, recall number Z-1728-2026. For more details, refer to the FDA website.

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 is recalling 439 medical convenience kits due to a potential risk of syringe disconnection during use, 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 "high" severity. Take precautions and monitor for updates.
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.