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, PREGNANT, PETS
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
- Preconnect with TENACIO Pump with InhibiZone
- Model numbers
- UPN: 72404461 (12CM PS IZ), 72404462 (14CM PS IZ), 72404463 (16CM PS IZ), 72404464 (18CM PS IZ), 72404465 (10CM IP IZ), 72404466 (12CM IP IZ), 72404467 (14CM IP IZ), 72404468 (16CM IP IZ) +1 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 CXR Preconnect with TENACIO Pump with InhibiZone is a medical device used in clinical settings. It combines a preconnect component with a TENACIO pump and an InhibiZone feature for protective purposes.
Why This Is Dangerous
The device could experience inflation or deflation performance issues, potentially affecting pressure regulation or operation.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Impact is primarily clinical and logistical. Hospitals and patients may face device downtime and the need for remediation, with potential treatment delays.
Practical Guidance
How to identify if yours is affected
- Review UPNs against 72404461 to 72404469
- Check lot numbers for the listed sequences (e.g., 1100398868 through 1100599107 as applicable)
- Verify device configuration PS IZ or IP IZ
Where to find product info
Manufacturer recall notices and FDA enforcement page Z-0143-2026 provide identifiers like UPNs, LOT numbers, and UDI-DI.
What timeline to expect
Remediation timelines vary; contact Boston Scientific for specific timelines on refunds or replacements.
If the manufacturer is unresponsive
- Document all communications
- Contact FDA or applicable health authority for escalation
How to prevent similar issues
- Ensure devices are sourced through approved channels
- Maintain up-to-date device inventory with serials and UPNs
- Stay informed on FDA recall updates and manufacturer notices
Documentation advice
Keep recall notices, communications with healthcare providers, serials, LOts, and replacement confirmations.
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Product Details
Product: CXR Preconnect with TENACIO Pump with InhibiZone. UPNs include 72404461, 72404462, 72404463, 72404464, 72404465, 72404466, 72404467, 72404468, 72404469. Classification: Class II recall. Quantity: 172 units. Distribution: Worldwide, including US nationwide and Canada.
Reported Incidents
No injury counts or specific incident narratives are provided in the recall notice. The hazard level is listed as HIGH.
Key Facts
- Class II medical device recall
- Inflation/deflation performance risk
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Safety Guide
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