Medline Industries Recalls Adult Intubation Trays Over Life-Threatening Catheter Size Error
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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 April 6, 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 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, MedicalDevice.
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 ↗
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