Cook Aurous Centimeter Sizing Catheter Recall
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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 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 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 ↗
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