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Boston Scientific Corporation recalls EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Recalled March 18, 2026 · FDA recall Z-1551-2026 · Boston Scientific
Hazard
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit. · FDA Class II
Units
806 units
Sold at
US Nationwide distribution.
Description
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Product
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →