FDAFDA · Food and drugs·Recall number Z-0139-2026
TENACIO Pump without InhibiZone; UPN: 72404420;
Published October 22, 2025 · Recall initiated: September 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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