Class III — LINEAGE BIOMEDICAL, INC
| Recalling firm | Lineage Biomedical, Inc |
|---|---|
| Registered facility | LINEAGE BIOMEDICAL, INC (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Incorrect GTIN number on carton. |
| Product | NavaClick Syringe and Needle, Model Number LIN02 |
| Quantity | 215 cartons (containing 50 pouches each) |
| Distribution | US Nationwide distribution in the states of Michigan and South Carolina. |
| Initiated | 2024-07-12 |
| Classified | 2024-08-08 |
| Recall number | Z-2535-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — LINEAGE BIOMEDICAL, INC (Z-2535-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94963/
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