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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Halyard ENT and CPT Basic IR Packs Recalled for Open Bag Seals

Agency Publication Date: September 5, 2025
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Summary

AVID Medical, Inc. is recalling 285 units of Halyard ENT and CPT Basic IR Packs because the header bag seals may be open, which compromises the sterility of the medical instruments inside. The recall includes ENT Pack model JACK421-04 and CPT Basic IR Pack model 1646381. Because these are convenience kits used in medical procedures, using a pack with a compromised seal could introduce contaminants to patients.

Risk

The open bag seals fail to maintain a sterile barrier for the medical equipment. Using non-sterile surgical instruments poses a significant risk of infection or other complications to patients during medical procedures.

What You Should Do

  1. This recall affects Halyard ENT PACK (Model JACK421-04) and Halyard CPT BASIC IR PACK (Model 1646381) convenience kits. Affected ENT packs have Lot Number 1647218 (Exp 7/17/2027), and affected CPT Basic IR packs have Lot Number 1646381 (Exp 1/31/2028).
  2. Stop using the recalled device immediately.
  3. Contact AVID Medical, Inc. or your distributor to arrange for the return, replacement, or correction of the affected packs.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Halyard, ENT PACK
Variants: Convenience kit
Model / REF:
JACK421-04
Lot Numbers:
1647218 (Exp 7/17/2027)
UDI:
10809160462973

Recall #: Z-2530-2025; Quantity: 57 units

Product: Halyard, CPT BASIC IR PACK
Variants: Convenience kit
Model / REF:
1646381
Lot Numbers:
1646381 (Exp 1/31/2028)
UDI:
10809160363256

Recall #: Z-2531-2025; Quantity: 228 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97452
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 2 products (57 units; 228 units)
Distributed To: Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.