Z-2535-2024Class III

NavaClick Syringe and Needle, Model Number LIN02

Name: Z-2535-2024 NavaClick Syringe and Needle, Model Number LIN02
Creator: Lineage Biomedical, Inc
Published: 2024-07-12
License: https://open.fda.gov/license/

Lineage Biomedical, Inc / initiated 2024-07-12 / Open, Classified / root cause: labeling and UDI

FDA source

LINEAGE BIOMEDICAL, INC began a recall of NavaClick Syringe and Needle, Model Number LIN02 on 2024-07-12. FDA classified it as Class III and gives the reason as "Incorrect GTIN number on carton". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2535-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-07-12
Posted: 2024-08-08
Recalling firm: Lineage Biomedical, Inc
Product: NavaClick Syringe and Needle, Model Number LIN02
Product code: FMF Syringe, Piston
Reason for recall: Incorrect GTIN number on carton.
Root cause tag: labeling and UDI
FDA 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 in commerce: 215 cartons (containing 50 pouches each)
Distribution: US Nationwide distribution in the states of Michigan and South Carolina.
Product codes and lots: Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2535-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2535-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08

Product code FMF

K231877Class IINavaClick Injection SystemLineage Biomedical, Inc. / cleared 2023-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)