Reported Sep 17, 2025 · Ongoing

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

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565

Is this the product you have?

  • Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Lot codes and dates
  • Batch108159110
Amount recalled
1 unit

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.