# FDA recall Z-2551-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-08-18.

## Product

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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2551-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-18
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2551-2025

## Citation

> AI Analytics. FDA recall Z-2551-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-2551-2025. Source: US FDA. Licensed CC0.

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