Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-2551-2025)

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:

Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

Product Classification:

Class II

Date Initiated: August 18, 2025

Date Posted: September 17, 2025

Recall Number: Z-2551-2025

Event ID: 97466

Reason for Recall:

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Batch: 108159110

Distribution Pattern:

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

Voluntary or Mandated:

Voluntary: Firm initiated