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All product recalls associated with KCI USA, INC..
Total Recalls
14
Past Year
2
Class I (Serious)
0
Most Recent
Jan 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.
Due to increase in complaints related to leak alarms
Due to increase in complaints related to leak alarms
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
Power cords may crack and fail inside plug with potential for fire hazard.
Power cords may crack and fail inside plug with potential for fire hazard.
Power cords may crack and fail inside plug with potential for fire hazard.
Power cords may crack and fail inside plug with potential for fire hazard.
Power cords may crack and fail inside plug with potential for fire hazard.
Power cords may crack and fail inside plug with potential for fire hazard.
The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.