Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Product type
- Cryoablation System
- Model numbers
- FPRCH8000, FPRCH8000-02, H749396118000
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
The ICEfx Cryoablation System is a portable, helium-free desktop cryoablation device used in medical procedures. It is designed for clinical settings and requires professional operation.
Why This Is Dangerous
End caps on desiccant tube subassemblies were not tightened during manufacturing. This could affect device integrity or introduce desiccant material into the system, potentially compromising sterile barriers.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must identify affected units and halt use. The recall affects 19 units distributed worldwide, with potential patient safety implications if devices are used before remediation.
Practical Guidance
How to identify if yours is affected
- Verify model numbers against FPRCH8000, FPRCH8000-02, and H749396118000.
- Check your recall notification letter for device identifiers.
- Determine if the unit was distributed in the US, Canada, France, Germany, or Italy.
Where to find product info
Refer to the FDA recall page for Z-2550-2025 and the manufacturer’s recall communications.
What timeline to expect
Recall remedies are issued by the manufacturer. Processing timelines for replacements or refunds typically span several weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- If the company is slow to respond, escalate to FDA recall resources or your healthcare facility’s administration for support.
How to prevent similar issues
- Verify device recalls during procurement and routine audits in clinical settings.
- Keep manufacturer recall communications and serial/model data readily accessible.
- Review hospital recall procedures and ensure rapid isolation of affected devices.
Documentation advice
Keep the recall letter, model numbers, serial numbers, and all correspondence with the manufacturer for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: FPRCH8000, FPRCH8000-02, H749396118000 Sold worldwide with US nationwide distribution; also in Canada, France, Germany and Italy Quantity recalled: 19 units Manufacturer: Boston Scientific Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US, Canada, France, Germany, Italy
- End caps on desiccant tube subassemblies not tightened
- Stop using the device immediately
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.