EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number ...
FDA Recall #Z-1551-2026 — Class II — February 10, 2026
Product Description
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 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.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
806 units
Distribution
US Nationwide distribution.
Code Information
Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Outer Box UDI: 08714729880394; Inner Box UDI: 08714729880387; Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292; Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated