NavaClick Syringe and Needle, Model Number LIN02 recallZ-2535-2024 · Lineage Biomedical, Inc · initiated Jul 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Lineage Biomedical, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect GTIN number on carton.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-2535-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 12, 2024
- Posted by the FDA
- Aug 8, 2024
- Recalling firm
- Lineage Biomedical, Inc
- Quantity
- 215 cartons (containing 50 pouches each)
- Product code
- FMF
- FDA submissions
- K231877
- Distribution
- US Nationwide distribution in the states of Michigan and South Carolina.
Product description
NavaClick Syringe and Needle, Model Number LIN02
Code information (models, lots, serial numbers)
Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NavaClick Syringe and Needle LIN02Lineage Biomedical, Inc. · Syringe, Piston1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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