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
- Preventive Maintenance Kit
- Model numbers
- SPRPM8000
- 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
Why This Is Dangerous
The incorrectly tightened end caps on the desiccant tubes can lead to malfunction of the entire system, potentially endangering patient health. Proper assembly is critical for the safe functioning of the kit.
Industry Context
This recall is not part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Locate the model number SPRPM8000 on the product packaging or device.
- Check for any recall notifications from Boston Scientific or regulatory bodies.
- Review any recent communications from healthcare providers regarding this product.
Where to find product info
Model numbers and related identifiers are typically on the product label or inside the packaging.
What timeline to expect
Refund or replacement processing usually takes about 4-8 weeks after the product is returned.
If the manufacturer is unresponsive
- Follow up with Boston Scientific customer support for updates.
- Document all correspondence and attempts to contact them.
How to prevent similar issues
- Always verify if a product has been recalled before purchase.
- Check for any associated safety certifications on medical devices before buying.
- Stay informed about recalls through official channels.
Documentation advice
Keep copies of all receipts, correspondence regarding recalls, and any notification letters from the manufacturer.
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Product Details
- Brand: Boston Scientific - Model: SPRPM8000 - Quantity recalled: 1 unit - Distribution: Worldwide - US, Canada, France, Germany, Italy
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed worldwide including the US, Canada, France, Germany, Italy
- Hazard involves incorrectly tightened end caps on desiccant tubes
- Patients should stop using the device immediately
- Contact Boston Scientific for more information
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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