Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Reported: September 17, 2025 Initiated: August 18, 2025 #Z-2551-2025
Product Description
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 1 unit
- Distribution
- Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000. Recalled by Boston Scientific Corporation. Units affected: 1 unit.
Why was this product recalled? ▼
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2551-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11