Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-0140-2026)

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:

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Product Classification:

Class II

Date Initiated: September 11, 2025

Date Posted: October 22, 2025

Recall Number: Z-0140-2026

Event ID: 97603

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1 unit

Code Information:

1. UPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852; 2. UPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated