Cook Centimeter Sizing Catheter 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 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 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, fda, Medical Devices.
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 ↗
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 (1,367 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.