Cook Medical Ciaglia Blue Rhino Tracheostomy Introducer Set Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 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, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,623 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.