Boston Scientific Corporation

Device Recalls (Class II)

← All 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.