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All product recalls associated with Cook Incorporated.
Total Recalls
1000
Past Year
123
Class I (Serious)
69
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 may have low seal strength and not meet peel strength specifications, compromising device sterility
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
The product does not meet sterility assurance level.
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.
Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.
cGMP Deviations: Products were stored outside the drug label specifications.
cGMP Deviations: Products were stored outside the drug label specifications.
cGMP Deviations: Products were stored outside the drug label specifications.
Due to reports of intraoperative graft bolt implantation breakages.
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
The ingredient Triticale is not identified as wheat.