Recall of Medline Medical Convenience Kits

Source: FDA · United States

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Medline Industries, LP is recalling 3120 kits of medical convenience kits due to a potential risk of syringe adaptors 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 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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Recall of Medline Medical Convenience Kits

What Happened

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/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, labeled as CVOR ANGIOGRAPHY PACK-LF with Medline SKU DYNJ42367B. The recall involves 3120 kits with the following codes: UDI/DI each 10193489211511, UDI/DI case 40193489211512, and Lot Numbers: 24FBJ579, 24DBL828, 24DBE055, 24CBG967, 24ABN254, 23LBI540, 23KBF222, 23JBM761, 23JBA270, 23HBY791, 23HBD212, 23GBJ794, 23FBK893, 23EBQ313, 23DBC465. These products were distributed worldwide, including US nationwide, Puerto Rico, and countries such as Canada, Netherlands, Australia, Korea, Republic of, 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 visit from Medline Industries, LP, for instructions on the recall. Contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for returns or refunds related to this recall.

Why This Matters

This recall is classified as Class I, indicating a reasonable probability of serious adverse health consequences. It affects medical devices used in procedures, potentially leading to risks if connections fail.

Source

FDA recall notice Z-1714-2026

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 3120 kits of medical convenience kits due to a potential risk of syringe adaptors 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 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.