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
- Inflation/Deflation Pump
- Model numbers
- UPN: 72404429, UDI-DI: Lot numbers: 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139 +12 more
- 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 with InhibiZone is a medical device used in clinical settings. It is designed to assist in specific implant or therapeutic procedures and is distributed internationally by Boston Scientific.
Why This Is Dangerous
The device may fail to inflate or deflate as intended, which could compromise performance during use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
If the device underperforms, patients may require additional medical evaluation or procedures. No injuries have been reported to date, but the recall could affect ongoing treatments.
Practical Guidance
How to identify if yours is affected
- Check the device labeling for UPN 72404429.
- Cross-check lot numbers against the list provided in the recall notice.
- Review the manufacturer notification letter for exact steps.
Where to find product info
Identifiers are on the device label, packaging, and recall notice.
What timeline to expect
Refunds or replacements typically take 4-8 weeks once processed by the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with consumer protection agencies if the company is slow to respond.
- Consult your healthcare provider for interim treatment options.
How to prevent similar issues
- Verify recall status before using any device.
- Register products with the manufacturer if applicable.
- Keep recall communications for reference.
- Be attentive to recall updates from FDA and the manufacturer.
Documentation advice
Keep the recall letter, save all communications, photograph labels and serial numbers, and retain proof of purchase when available.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US and Canada
- Lot numbers listed for verification
- No injuries reported at this time
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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