AVID Medical, Inc. medical device recall: Halyard ORGAN RECOVERY OR PACK
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98060
- Recall initiated
- Nov 11, 2025
- Classified by FDA
- Jan 2, 2026
- Posted in Enforcement Report
- Jan 14, 2026
- Recalling firm
- AVID Medical, Inc.
- Firm location
- Toano, VA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Devices are not suitable for organ transplant.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Nov 11, 2025. FDA classified it 52 days later, on Jan 2, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide distribution in the states of FL, GA and Puerto Rico. AVID Medical, Inc. has 28 recalls in our records.
Recalled products (3)
Z-1000-2026 Class I Ongoing
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Codes / lots: Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.
Quantity: 132 units
Z-1001-2026 Class I Ongoing
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Codes / lots: Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
Quantity: 52 units
Z-1002-2026 Class I Ongoing
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Codes / lots: Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Quantity: 380 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98060
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.