Cook Aurous 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 has initiated a Class I recall of 271 Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage.
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, Devices.
What Happened
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters because marker bands may be at increased risk of cracking or breakage. Potential adverse events include increased procedural time, harms from device fragmentation or 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 Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308. A total of 271 units are affected. UDI-DI 00827002473089. Affected lots: 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, 16713191. The products are single-use sterile catheters with gold marker bands for angiographic procedures. 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. Recall number Z-1935-2026. Recall initiation date April 2, 2026.
What You Should Do
Consumers and healthcare providers should follow any instructions provided by Cook Incorporated regarding the recalled devices.
Why This Matters
This is a Class I recall, indicating a reasonable probability of serious adverse health consequences or death.
Source
FDA recall Z-1935-2026 (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 (1,388 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.