Medline Medical Convenience Kits Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

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 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

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 ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
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.