Boston Scientific Corporation
Device Recalls (Class II)
Class II
Z-1551-2026
·
20260318
·
Ongoing
Product
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Reason for Recall
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 Bosto...
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API