Z-0138-2026 Class II Ongoing
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
- 59 units
Product Description
TENACIO Pump with InhibiZone; UPN: 72404429;
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: 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;