The Recall Desk
Severity pendingFDA (Devices)·Z-2530-2025·Announced 2025-09-17

Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

Pending LLM rewrite. Source: FDA_DEVICE Z-2530-2025.

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

Potential for open header bag seals, compromising sterility.

The recalled product

Product
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Manufacturer
AVID Medical, Inc.

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 (2)

  • Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218
  • Expiration Date: 7/17/2027.

Distribution

Distributed nationwide across the United States.