The Recall Desk
Severity pendingFDA (Devices)·Z-0139-2026·Announced 2025-10-22

TENACIO Pump without InhibiZone; UPN: 72404420;

Pending LLM rewrite. Source: FDA_DEVICE Z-0139-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

The recalled product

Product
TENACIO Pump without InhibiZone; UPN: 72404420;
Manufacturer
Boston Scientific Corporation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UPN: 72404420
  • UDI-DI: Lot numbers: 1100720566
  • 1100720567
  • 1100720568

Distribution

Distributed nationwide across the United States.