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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Halyard Organ Recovery and Mini Plus Kits Recalled: Not Suitable for Transplants

Agency Publication Date: January 2, 2026
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Summary

AVID Medical, Inc. is recalling 564 units of Halyard Organ Recovery Packs and Mini Plus Kits because they are not suitable for use in organ transplant procedures. The affected kits include Halyard Organ Recovery OR Packs (Kit Codes LLOG1000-15 and LLOF1000-17) and Halyard Mini Plus Kit South (Kit Code JACK097-08). The company initiated the recall after determining the devices should not be used for transplants, and notified customers via email in November 2025.

Risk

Using these kits in organ transplant surgeries may lead to serious surgical complications or transplant failure because the components are not appropriate for those specific medical procedures.

What You Should Do

  1. This recall affects Halyard Organ Recovery OR Packs and Halyard Mini Plus Kit South products with Kit Codes LLOG1000-15, LLOF1000-17, and JACK097-08.
  2. Check the kit label on the product packaging for Kit Code LLOG1000-15 (Lots 1632138, 1648393), Kit Code LLOF1000-17 (Lot 1651709), or Kit Code JACK097-08 (Lot 1654185). See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact AVID Medical, Inc. or your medical supply distributor to arrange for the return, replacement, or correction of the kits.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this 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 ORGAN RECOVERY OR PACKby Halyard
Variants: Kit Code: LLOG1000-15
Model / REF:
LLOG1000-15
Lot Numbers:
1632138
1648393
UDI:
10809160432679
Product: Halyard ORGAN RECOVERY OR PACKby Halyard
Variants: Kit Code: LLOF1000-17
Model / REF:
LLOF1000-17
Lot Numbers:
1651709
UDI:
10809160460726
Product: Halyard MINI PLUS KIT SOUTHby Halyard
Variants: Kit Code: JACK097-08
Model / REF:
JACK097-08
Lot Numbers:
1654185
UDI:
10809160462829

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98060
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: hospital supply distributors; medical supply channels
Manufactured In: United States
Units Affected: 3 products (132 units; 52 units; 380 units)
Distributed To: Florida, Georgia, Puerto Rico

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.