Cook Medical Ciaglia Blue Rhino Tracheostomy Introducer Set Recall

Source: FDA · Worldwide

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Cook Incorporated is recalling 484 units of the COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set due to incorrect expiration dates on the labels.

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

This notice was issued by FDA on April 23, 2026 and geographically references Worldwide. 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 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, 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.

What Happened

Cook Incorporated is recalling certain lots of the COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set because the products were labeled with expiration dates that exceed the true shelf life.

Which Products Are Affected

The affected products include the COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set with Reference Part Number C-PTIS-100-FLEX-HC (Order Number G32092) and Reference Part Number C-PTIS-100-HC (Order Number G12115). A total of 484 units are involved, with specific lots identified as follows: Lot Number NS16200246, NS16189601, NS16226797, NS16200247, NS16189598, NS16189586, NS16189600, 16120672, NS16189607 for C-PTIS-100-FLEX-HC; and Lot Number 16189604, 16189588, 16189603, 16189608, 16189589, 16189602, 16120666, 16189594 for C-PTIS-100-HC. The products have UDIs such as (01)00827002320925(17)270812(10)NS16200246 and others as listed. These were distributed worldwide.

What You Should Do

Consumers should follow the initial firm notification, which may include email, fax, letter, press release, telephone, or a visit, for instructions on the recall. Contact Cook Incorporated at their address, 750 N Daniels Way, Bloomington, IN 47404-9120, United States, for information on returns or refunds.

Why This Matters

This recall involves medical devices that could pose risks if used beyond their actual shelf life, affecting 484 units distributed worldwide and potentially impacting patient safety.

Source

This information is from the FDA recall notice with recall number Z-1781-2026. For more details, refer to 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?
Cook Incorporated is recalling 484 units of the COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set due to incorrect expiration dates on the labels.
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 Worldwide. 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.