Recall Z-1551-2026 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Boston Scientific Corporation
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
| Date | Mar 11, 2026 (initiated Feb 10, 2026) |
| Status | Open, Classified |
| 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. |
| Root 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 |
| Quantity | 806 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit C Boston Scientific Corp, May 29, 2015 |