Medline Industries Recalls Adult Intubation Trays Over Life-Threatening Catheter Size Error

Source: FDA · United States and Canada

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Medline Industries, LP is recalling specific adult intubation trays distributed in the U.S. and Canada due to an incorrectly sized suction catheter that could cause airway obstruction.

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

This notice was issued by FDA on February 25, 2026 and geographically references United States and Canada. 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.

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What Happened

Medline Industries, LP has initiated a voluntary recall of specific Intubation Trays (Adult) due to a packaging error. The company discovered that an 8 Fr suction catheter may have been included in the kits instead of the required 14 Fr suction catheter. The use of a smaller-than-intended catheter poses significant health risks, including hypoxia, respiratory failure, and partial or full airway obstruction. Such obstructions may require immediate emergency medical intervention to prevent death.

Which Products Are Affected

The recall involves 130 units distributed nationwide in the United States and Canada. Affected products include:

  • Product Name: Intubation Tray (Adult) containing Suction Catheter Kits
  • SKU: DYNJAA245B
  • Lot Numbers: 25IBC172 and 25HBJ413
  • UDI (each): 10198459480317
  • UDI (case): 40198459480318
  • Recall Number: Z-1313-2026

What You Should Do

Healthcare providers and facilities should immediately inspect their inventory for the affected SKU and lot numbers listed above. Medline Industries began notifying customers via letter on December 24, 2025. Any affected trays should be set aside and handled according to the instructions provided in the firm's notification letter. For further information regarding returns or replacements, contact Medline Industries, LP directly.

Why This Matters

This recall is critical because the incorrect catheter size can lead to life-threatening complications during intubation procedures, including airway irritation, prolonged dyspnea, or fatal respiratory failure if the airway becomes obstructed.

Source

Information provided by the FDA under recall event ID 98285.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling specific adult intubation trays distributed in the U.S. and Canada due to an incorrectly sized suction catheter that could cause airway obstruction.
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 and Canada. 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.