Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-0139-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

TENACIO Pump without InhibiZone; UPN: 72404420;

Product Classification:

Class II

Date Initiated: September 11, 2025

Date Posted: October 22, 2025

Recall Number: Z-0139-2026

Event ID: 97603

Reason for Recall:

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

Status: Ongoing

Product Quantity: 0 units

Code Information:

UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated