TENACIO Pump with InhibiZone — Class II medical device recall Z-0138-2026
Ongoing recall by Boston Scientific Corporation, reported 2025-10-22, distributed nationwide. The potential for devices to experience inflation and/or deflation performance issues or difficulties.
| Recall number | Z-0138-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 59 units |
| Lot numbers | 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551138, 1100551139, 1100551141, 1100551142, 1100551145, 1100551146, 1100551147, 1100551148, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590, 1100553591, 1100553592, 1100553594, 1100553595, 1100553596, 1100553597, 1100579593, 1100579595, 1100579596, 1100579598, 1100579599, 1100579600, 1100579601, 1100579639, 1100579640 and 52 more |
Product
TENACIO Pump with InhibiZone; UPN: 72404429;
Reason for recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0138-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.