Z-0139-2026 Class II Ongoing
FDA device recall Z-0139-2026 was initiated by Boston Scientific Corporation on September 11, 2025 and is designated Class II. Reason for recall: The potential for devices to experience inflation and/or deflation performance issues or difficulties. The recall status is ongoing. Affected quantity: 0 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 units
Product Description
TENACIO Pump without InhibiZone; UPN: 72404420;
Reason for Recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;