Medline Medical Convenience Kits Recall
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Medline Industries is recalling 17,902 medical convenience kits due to a potential risk of syringe disconnection during use, affecting products distributed worldwide including the US.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 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 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, 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 identified a potential risk where the syringe rotating adaptor in their medical convenience kits may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold. This recall is classified as Class I and was initiated voluntarily by the firm.
Which Products Are Affected
The affected products are various Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes, specifically:
- CATH LAB PACK-LF, Medline SKU 00-HCT055P
- INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q
- ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C
- ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C
- ANGIO DRAPE PACK, Medline SKU DYNJ47952B
- ANGIOGRAPHIC PACK, Medline SKU DYNJ57516
- CATH LAB PACK, Medline SKU DYNJ58243B
- CATH LAB PACK, Medline SKU DYNJ65185
- CSU CATH MANIFOLD KIT, Medline SKU VASC1170A
- MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A
A total of 17,902 kits are affected, with specific lot numbers provided in the recall details. These products were distributed worldwide, including nationwide in the US and Puerto Rico, as well as to countries such as Canada, Netherlands, Australia, and others. Each product has associated UDI/DI codes, such as 10193489297393 for individual units and 40193489297394 for cases, among many others listed.
What You Should Do
Consumers and healthcare providers should follow the initial firm notification, which may include methods like email, fax, letter, press release, telephone, or visit, to receive instructions from Medline Industries, LP. Contact the recalling firm for details on returning or handling the affected products.
Why This Matters
This recall involves medical devices that could lead to serious health risks if the syringe disconnects during procedures, highlighting the importance of device safety in healthcare. It affects a significant number of kits distributed globally, potentially impacting patient care.
Source
This information is from the FDA recall notice with recall number Z-1716-2026. For more details, visit the FDA website at https://www.fda.gov/ or search for event ID 98598.
Original source: FDA Official Notice ↗
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