Boston Scientific Corporation recalls EndoVive Safety PEG Kit

Recalling company

Boston Scientific Corporation

Product

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 10, 2026

Reported

Mar 18, 2026

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

806 units

Lot / codes

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;

Company location

Marlborough, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1551-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1551-2026 in the FDA Enforcement Report. Also see FDA recall press releases.