Medline Industries Recall of Medical Device Kits

Source: FDA · United States

Medline Industries, LP is recalling over 160,883 units of various medical device kits due to rescinded regulatory clearances for certain components.

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

This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" 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, cpsc, 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.

Medline Industries Medical Device Kits Recall

What Happened

Medline Industries, LP is voluntarily recalling the affected medical device kits because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Which Products Are Affected

The recall involves multiple models of medical device kits, including but not limited to: CATH LAB CDS (Model: CDS840228F), IR PACK (Model: DYNDH2104), and CARDIAC CATH PACK-LF (Model: DYNJT2164M), among others listed in the recall notice. A total of 160,883 units are affected, distributed nationwide in the United States. Specific lots include various numbers such as 25ALA420 for CDS840228F and 25DBR609 for DYNDH2104. Model numbers and UDIs are provided in the source data, with the official recall number Z-1835-2026.

What You Should Do

Consumers should contact Medline Industries, LP for instructions on returning the affected products. The initial firm notification was made via letter, and further details can be obtained from the recalling firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall highlights potential regulatory compliance issues in medical devices, which could affect patient safety and require healthcare providers to verify product approvals to ensure proper use.

Source

Attribution: FDA Recall Notice Z-1835-2026. For more information, visit the FDA website at https://www.fda.gov.

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 over 160,883 units of various medical device kits due to rescinded regulatory clearances for certain components.
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 "medium" severity. Stay informed and follow agency guidance.
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.