Cook Centimeter Sizing Catheter Recall

Source: FDA · United States

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 11,253 Centimeter Sizing Catheters due to risk of marker band cracking or breakage, which may lead to life-threatening harm.

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

This notice was issued by FDA on May 27, 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, Medical 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 Centimeter Sizing Catheters because marker bands may be at an increased risk of cracking/breakage. Potential adverse events include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

Which Products Are Affected

The recall involves Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916. A total of 11,253 units are affected. The recall covers specific lots identified by the following codes: 16905390, 16905390X, 16888263, NS16888264, 16905391, 16905391X, 16909577, 16918137, 16924645, 16924646, 16928311, 16928311X, 16928312, 16928313, 16947353 and many additional lots (full list available via recall number). Distribution was nationwide in the United States and to Brunei, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, and Uruguay.

What You Should Do

No specific consumer action steps are provided in the recall notice.

Why This Matters

This is a Class I recall, the most serious type, indicating a reasonable probability of serious adverse health consequences or death.

Source

FDA recall number Z-1934-2026 (event ID 98682).

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 11,253 Centimeter Sizing Catheters due to risk of marker band cracking or breakage, which may lead to life-threatening harm.
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.