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Stop using now Medical device recall · FDA · Published November 11, 2025

AVID Medical Halyard Organ Recovery Pack: Not Suitable for Organ Transplant

AVID Medical recalls Halyard Organ Recovery Pack (Kit Code LLOF1000-17) due to being unsuitable for organ transplant procedures. Affected units have specific UDI and lot numbers.

🇺🇸 FDA recall #Z-1001-2026Medical deviceAVID Medical ›
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Contact the company

Recalling firmAVID Medical, Inc.9000 Westmont Dr · Toano, VA 23168-9351
✎ GovInfoNow plain-language explainer

What happened, in plain English

AVID Medical is recalling their Halyard Organ Recovery Pack (Kit Code LLOF1000-17) because it is not designed for organ transplant use. This could lead to serious complications if used incorrectly in transplant procedures. Read more at govinfonow.com/recall/50682-avid-medical-halyard-organ-recovery-pack-not-suitable-for-organ.

Source Summary by GovInfoNow · govinfonow.com/recall/50682-avid-medical-halyard-organ-recovery-pack-not-suitable-for-organ · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1001-2026

Cite this page

“AVID Medical Halyard Organ Recovery Pack: Not Suitable for Organ Transplant.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50682-avid-medical-halyard-organ-recovery-pack-not-suitable-for-organ. Based on FDA recall #Z-1001-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2026%22&limit=1).

Why it’s dangerous

The organ recovery pack is not designed for use in organ transplant procedures. Using it for this purpose could cause serious complications or harm to the patient during the transplant process.

Who’s affected

Healthcare professionals using this organ recovery kit for transplant procedures are affected. Patients undergoing organ transplants using this kit are at risk of serious complications.

How to tell if you have this one

Check for Kit Code LLOF1000-17 on the product. Units with UDI number 10809160460726 and Lot Number 1651709 are affected.

  • Brand
    AVID Medical
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of FL, GA and Puerto Rico.
Recall numberProduct, codes & lotsQuantity
Z-1000-2026Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.; Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.132 units
Z-1001-2026Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.; Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 165170952 units
Z-1002-2026Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08; Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.380 units
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using the Halyard Organ Recovery Pack if it has Kit Code LLOF1000-17.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution in the states of FL, GA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, Puerto Rico.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Nov 11, 202512. FDA classified it Class I: Jan 2, 202623. Published in FDA’s Enforcement Report: Jan 14, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1001-2026 (November 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1001-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA