Recall archive / FDA device enforcement
TENACIO Pump with InhibiZone; UPN: 72404429; — FDA record Z-0138-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TENACIO Pump with InhibiZone; UPN: 72404429;
- Reason
- The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 59 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0138-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UPN: 72404429; UDI-DI: Lot numbers: 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139, 1100551145, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590, 1100553591, 1100553594, 1100553595, 1100553596, 1100579593, 1100579596, 1100579598, 1100579599, 1100579600, 1100579639, 1100579640, 1100579642, 1100579643, 1100579646, 1100580141, 1100580143, 1100580144, 1100580145, 1100580146, 1100580149, 1100580598, 1100580599, 1100580600, 1100580601, 1100580605, 1100580608, 1100580609, 1100580610, 1100580612, 1100678770, 1100678774, 1100678775, 1100678776, 1100679129, 1100687128, 1100687130, 1100687133, 1100687134, 1100687135, 1100687140, 1100687142, 1100717769, 1100717773, 1100717774, 1100717775, 1100717776, 1100553592, 1100551147, 1100551138, 1100553597, 1100551146, 1100551142, 1100551148, 1100551141, 1100579595, 1100580147, 1100580606, 1100579641, 1100580607, 1100580595, 1100580603, 1100579601, 1100580148, 1100580597, 1100580596, 1100580613, 1100580611, 1100678777, 1100687129, 1100679130, 1100678773, 1100721233, 1100721238; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 22, 2025
- Recall initiation date
- Sep 11, 2025
- Center classification date
- Oct 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.