Summary
The FDA issued a Class I for Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. by AVID Medical, Inc.. Reason: Devices are not suitable for organ transplant..
Details
Source
Device Recall
External ID
Z-1000-2026
Action Date
2026-01-14
Status
Ongoing
Category
device
Product Description
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Lot/Code Info: Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.
Quantity Affected: 132 units
Reason for Recall
Devices are not suitable for organ transplant.
Distribution
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-11
Company
Toano, VA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 98 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AVID Medical, Inc. has 125 FDA actions in our database, including 125 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVID Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVID Medical, Inc. have FDA actions?
AVID Medical, Inc. has 125 FDA actions in our database, including 125 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1000-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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