Class 2 Device Recall EndoViveTM Safety PEG Kit

• Date Initiated by Firm: February 10, 2026
• Date Posted: March 11, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1551-2026
• Recall Event ID: 98412
• 510(K)Number: K150679
• Product Classification: Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
• Product: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000
• 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
• FEI Number: 3005099803
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Renee Archie; 508-683-4523
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 806 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PIF