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[Recalled] Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 — Certain desiccant tube subassemblies were built with end caps that were not cor… | FDA 2025-08-18

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductPreventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Brand / manufacturerBoston Scientific Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2551-2025
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date18 August 2025
EAN / barcode108159110

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Boston Scientific Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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