Preventive Maintenance recall
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Why was Preventive Maintenance recalled?
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch: 108159110
- Product
- Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1 unit
- Distribution
- Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)