—#218643

Product

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

FDA product code: PIF — Gastrointestinal Tubes With Enteral Specific Connectors
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K150679
Affected lot / code info: 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;

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On February 10, 2026 Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: " Do NOT use affected product (Attachment 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific. " Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. " Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. " Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions. " Return affected product. This removal affects only the products and lots affected. No other material numbers or lots are impacted by this removal. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2026-02-10
Posted by FDA: 2026-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218643. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.