FDA Medical devices recall ·
TENACIO Pump without InhibiZone recall
- Recall number
- Z-0139-2026
- Date
- (initiated September 11, 2025)
- Company / brand
- Boston Scientific Corporation
100 Boston Scientific Way, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 0 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TENACIO Pump without InhibiZone; UPN: 72404420;
Why was it recalled?
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0139-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.