FDA Medical Device Recalls (openFDA)
LINEAGE BIOMEDICAL, INC: NavaClick Syringe and Needle, Model Number LIN02
- Recall number
- Z-2535-2024
- Recalling firm
- LINEAGE BIOMEDICAL, INC
- Product
- NavaClick Syringe and Needle, Model Number LIN02
- Status
- Open, Classified
- Initiated
- 2024-07-12
- Posted
- 2024-08-08
- Terminated
- not on file
- Reason
- Incorrect GTIN number on carton.
- Root cause
- Error in labeling
- Action
- Lineage Biomedical notified consignees via UPS letter on 07/12/2024. The letter instructed consignees to relabel the product with the updated UDI barcode or return inventory on hand for replacement. Additionally, consignees were asked to acknowledge receipt of the notification.
- Quantity
- 215 cartons (containing 50 pouches each)
- Distribution
- US Nationwide distribution in the states of Michigan and South Carolina.
- Lot, serial or model codes
- Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107
- 510(k) numbers
- ["K231877"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3030201489
- Firm city
- Stuart
- Firm state
- FL
- 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