FDA Device recall Z-2551-2025
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 by Boston Scientific, citing certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2551-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Reason
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Identifiers
| code_info | Batch: 108159110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2551-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.