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All product recalls associated with Cook, Inc..
Total Recalls
163
Past Year
7
Class I (Serious)
5
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
Lack of assurance of sterility, as the packages may not have been sealed.
These catheters do not include the proximal sidehole as required by the specification.
The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.
The side of the boxes give incorrect sizes for these stents. The label front is correct.
Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.
The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.
The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
Mislabeled as to size.
The reorder number listed on the product label is inaccurate.