FDA Device recall Z-0139-2026
TENACIO Pump without InhibiZone
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of TENACIO Pump without InhibiZone by Boston Scientific, citing the potential for devices to experience inflation and/or deflation performance issues or difficulties.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0139-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-11 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
TENACIO Pump without InhibiZone; UPN: 72404420;
Reason
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Identifiers
| code_info | UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0139-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.