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Recall Canary
Centimeter Sizing Catheter
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MEDICAL DEVICE RECALLCRITICAL

Centimeter Sizing Catheter

Cook is recalling Centimeter Sizing Catheters due to a risk of marker band breakage that may cause vessel injury or life-threatening harm.

What to do

Immediately stop using the affected catheters and contact Cook Incorporated for return and replacement instructions.

Posted
Updated
Recall No.
Z-1935-2026
Agency
Firm
Cook Incorporated
Recall ID
98682
Status
ONGOING

Why it was recalled

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result 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.

How to identify it

UPC 00827002473089 16858459 16869145 16857138 16763324 16750208 16752733 16821053

Aurous Centimeter Sizing Catheter

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification