Medline Medical Convenience Kits Recall Over Syringe Connection Risk

Source: FDA · Worldwide

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Medline Industries, LP is recalling 2980 medical convenience kits due to a potential risk of the syringe rotating adaptor unwinding, which could lead to disconnections.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references Worldwide. 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.

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, fda, 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.

What Happened

Medline Industries, LP has initiated a recall because of a potential risk where 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 affected products are Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes, specifically: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A. A total of 2980 kits are involved, with the following details: For DYNJ68037C, UDI/DI each 10198459239328, UDI/DI case 40198459239329, Lot Number: 25HBV397; For DYNJ89845, UDI/DI each 10198459292460, UDI/DI case 40198459292461, Lot Number: 25CBU222; For DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, and Lot Numbers: 26BBC195, 26ABI611, 25LBK402, 25KBH371, 25IBK975, 25HBQ426. These products were distributed nationwide in the US, including Puerto Rico, and to countries such as Canada, Netherlands, Australia, Korea, Sri Lanka, Pakistan, Japan, United Arab Emirates, Singapore, and Slovakia.

What You Should Do

Consumers should follow the initial firm notification, which may include email, fax, letter, press release, telephone, or a visit, for instructions on how to handle the affected products. Contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for information on returns or refunds.

Why This Matters

This Class I recall highlights potential serious health risks associated with medical devices, emphasizing the importance of ensuring reliable connections in medical procedures to prevent adverse events.

Source

Attribution: FDA Recall Number Z-1719-2026. For more information, visit the FDA website at the appropriate recall page.

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 2980 medical convenience kits due to a potential risk of the syringe rotating adaptor unwinding, which could lead to disconnections.
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 Worldwide. 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.