Quick Facts at a Glance
- Recall Date
- September 11, 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
- Infusion/Inflation Pump
- Model numbers
- UPN: 72404420, 1100720566, 1100720567, 1100720568
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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 TENACIO Pump is a medical device produced by Boston Scientific used in infusion-related therapies. The recall concerns inflation/deflation performance issues.
Why This Is Dangerous
A defect could cause unreliable inflation or deflation, potentially affecting therapy delivery or device function.
Industry Context
This recall is not described as part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Verify device model UPN 72404420
- Review FDA recall listing and manufacturer instructions
Where to find product info
Recall letter from Boston Scientific or healthcare provider; device labeling; Boston Scientific website; FDA recall page
What timeline to expect
Unknown; manufacturer guidance will dictate replacement or remediation timing
If the manufacturer is unresponsive
- Document every contact attempt with Boston Scientific and your provider
- Consider filing a complaint with FDA if the company does not respond in a timely manner
How to prevent similar issues
- Register devices with your facility or hospital recall program
- Monitor recall updates from FDA and manufacturer
- Ask healthcare providers about recall status before future device use
Documentation advice
Keep the recall notice, preserve device for records, document communications with manufacturer and providers
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Product Details
Model numbers: UPN 72404420; Lot numbers/UDI-DI: 1100720566, 1100720567, 1100720568. Sold worldwide, including the US and Canada. Recall date: 2025-09-11. Manufacturer: Boston Scientific Corporation. Status: Active. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UPN 72404420 is the identified model
- Lot numbers 1100720566, 1100720567, 1100720568 are associated with this recall
- Worldwide distribution including US and Canada
- Recall date 2025-09-11; status ACTIVE
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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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