FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
- Recall number
- Z-1000-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
- Status
- Open, Classified
- Initiated
- 2025-11-11
- Posted
- 2026-01-02
- Terminated
- not on file
- Reason
- Devices are not suitable for organ transplant.
- Root cause
- Nonconforming Material/Component
- Action
- An URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/11/25 was emailed to consignees instructing them to discontinue use of all recalled kits. Consignees are to discard all unused product. End users are to contact distributors with any questions they may have; Distributors are to forward the recall notification to customers who received distributed product. Adverse events or quality problems can be reported to Owens & Minor at complaints@owens-minor.com. An updated URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/17/25 was email to consignees instructing consignees to segregate and quarantine all impacted product remaining in inventory. Consignees are to discontinue use of the 24x30 poly bag included in the affected kits and add the provided warning label to ensure the component is discarded.
- Quantity
- 132 units
- Distribution
- US Nationwide distribution in the states of FL, GA and Puerto Rico.
- Lot, serial or model codes
- Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28