Recall of Medline Medical Convenience Kits Due to Syringe Risk
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Medline Industries is recalling 240 kits of their medical convenience kits because of a potential risk of syringe disconnection during use.
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 and International. 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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What Happened
Medline Industries, LP has identified 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 GLOVE PACK 7.0 (15PK), with Medline SKU # DYNJ63673D. The recall involves 240 kits, with Lot Number 25GLA141, UDI/DI for each unit as 10195327304843, and for the case as 40195327304844. These products were distributed nationwide in the United States, including Puerto Rico, and internationally to countries such as Canada, Netherlands, Australia, Korea, Republic of, Sri Lanka, Pakistan, Japan, United Arab Emirates, Singapore, and Slovakia.
What You Should Do
Consumers who have the affected kits should check for the specified Lot Number and contact Medline Industries, LP using the initial firm notification methods, which include email, fax, letter, press release, telephone, or visit, for further instructions on returns or refunds.
Why This Matters
This recall is significant as it addresses a potential safety issue in medical devices that could lead to complications during procedures, highlighting the importance of proper device functionality in healthcare settings.
Source
FDA recall notice for event ID 98598, recall number Z-1725-2026. Attribution: U.S. Food and Drug Administration (FDA).
Original source: FDA Official Notice ↗
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