FDA Recall of Cook Medical Blue Rhino G2-Multi Tracheostomy Introducer Tray

Source: FDA · Worldwide

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Cook Incorporated is recalling 441 units of its Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray 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 22, 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, 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.

What Happened

Cook Incorporated is recalling certain lots of the COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray because the products were labeled with expiration dates that exceed the true shelf life, potentially affecting their usability.

Which Products Are Affected

The affected products include the following Reference Part Numbers: C-PTISY-100-HC-G-NA (Order Number G57703), C-PTISY-100-UNL-HC-G-NA (Order Number G57706), and C-PTISY-100-UNS-HC-G-NA (Order Number G57704). The recall involves specific Lot Numbers such as 16183353X, 16076948, 15473203X, 15476984X, 15719188X, 16205108, 16080161X, and 16435112. Additionally, the products have associated UDIs, including (01)00827002577039(17)270730(10)16183353X for C-PTISY-100-HC-G-NA Lot 16183353X. A total of 441 units are affected, with worldwide distribution. The recall number is Z-1780-2026.

What You Should Do

Consumers should follow the initial firm notification methods, which include email, fax, letter, press release, telephone, or visit, to obtain instructions from Cook Incorporated. Contact the firm for information on returns or refunds.

Why This Matters

This recall affects 441 units of medical devices distributed worldwide, highlighting potential risks from using products past their actual shelf life, which could impact patient safety.

Source

FDA recall notice, recall number Z-1780-2026.

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 441 units of its Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray 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.