Medical device recalls Moderate risk

Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

Recall date
August 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2551-2025
FDA classification
Class II
Brand / firm
Boston Scientific Corporation
Sold / distributed
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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