FDA Recall of Medline Airway Exam Kit

Source: FDA · United States

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Medline Industries is recalling 14,379 Airway Exam Kits due to potential risks from recalled components in the kits.

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

This notice was issued by FDA on April 15, 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 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.

Recall Article

What Happened

Medline Industries, LP is recalling Airway Exam Kits because they contain recalled Olympus biopsy valves. These valves have been associated with complaints of rubber fragment detachment, which could lead to a foreign body in a patient's tracheobronchial tree, potentially requiring intervention, and other risks such as inflammatory response, hypoxia, or prolonged procedures.

Which Products Are Affected

The affected product is the Airway Exam Kit, model DYKE1796. A total of 14,379 kits are involved, distributed nationwide in the United States, specifically in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, and TX. The codes include UDI-DI 10193489874716 (each) and 40193489874717 (case), with lots: 24CBT023, 24FBB701, 24LBL343, and 25GBP141. The recall was initiated on February 16, 2026, under recall number Z-1705-2026.

What You Should Do

Consumers who have the affected Airway Exam Kits should follow the recall notice and contact the recalling firm, Medline Industries, LP, for instructions on returns or refunds. The firm is located at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall affects medical devices used in procedures, potentially impacting patient safety by introducing risks of complications that could require additional medical intervention, highlighting the importance of quality control in healthcare products.

Source

FDA recall notice, recall number Z-1705-2026, available through the FDA website.

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 is recalling 14,379 Airway Exam Kits due to potential risks from recalled components in the kits.
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.