Recall Z-0138-2026— Boston Scientific Corporation

Name: FDA recall Z-0138-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2025-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: TENACIO Pump with InhibiZone; UPN: 72404429;. Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-09-11
Firm location: Marlborough, MA, United States

Product description

TENACIO Pump with InhibiZone; UPN: 72404429;

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.