Recall of Cook Medical Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets
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Cook Incorporated is voluntarily recalling 916 units of its Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets 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.
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What Happened
Cook Incorporated is recalling certain Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because the products were labeled with expiration dates that exceed the true shelf life.
Which Products Are Affected
The affected products include the following Reference Part Numbers: C-PTIS-100-HC-G-EU (Order Number G57685), C-PTIS-100-HC-G-NA (Order Number G57682), C-PTIS-100-UNL-HC-G-EU (Order Number G57687), and C-PTIS-100-UNS-HC-G-EU (Order Number G57686). Specific lots affected are listed with their UDIs and Lot Numbers, such as Lot Number 16189446 for C-PTIS-100-HC-G-EU, and others including 16189593, 16175956, 16175957, 16189597, 16175953, 16460934 for C-PTIS-100-HC-G-EU; 16514949 and 16175948 for C-PTIS-100-HC-G-NA; 15151627, 16131781, and 16471138 for C-PTIS-100-UNL-HC-G-EU; and 16175951, 16175949, 16174015, 16175955, 16174023, 16187746, 15548776, and 16429827 for C-PTIS-100-UNS-HC-G-EU. A total of 916 units are affected, with worldwide distribution.
What You Should Do
Consumers who have these products should follow the firm's notification, which was initiated via methods such as email, fax, letter, press release, telephone, or visit, and contact Cook Incorporated at their address: 750 N Daniels Way, Bloomington, IN 47404-9120, for further instructions on the recall.
Why This Matters
This recall addresses potential risks from using products past their actual shelf life, which could affect the safety and effectiveness of medical devices, impacting patient care on a worldwide scale.
Source
FDA recall notice: https://www.fda.gov/recalls (Recall Number Z-1779-2026). Attribution to the U.S. Food and Drug Administration.
Original source: FDA Official Notice ↗
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