Reported Sep 17, 2025 · Ongoing

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

AVID Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AVID Medical, Inc. · 9000 Westmont Dr · Toano, VA · 23168-9351

Is this the product you have?

  • Halyard, ENT PACK
  • Model NumberJACK421-04. Convenience kit
Lot codes and dates
  • Model NumberJACK421-04
  • UDI10809160462973
  • Lot Number1647218
  • Expiration Date7/17/2027
Amount recalled
57 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • FL

Why it was recalled

Potential for open header bag seals, compromising sterility.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.