Class II

Medical Device Recall: TENACIO Pump without InhibiZone; UPN: 72404420;

Boston Scientific Corporation · September 11, 2025

Reason for Recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

0 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0139-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Boston Scientific Corporation Medical Device Recall: TENACIO Pump without InhibiZone; UPN: 72404420; | SafeCheck