Exact FDA event identifier

Event 94963

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 12, 2024
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: LINEAGE BIOMEDICAL, INC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NavaClick Syringe and Needle, Model Number LIN02

Z-2535-2024

Recall number: Z-2535-2024
Initiated: July 12, 2024
Classification: Class III
Status: Ongoing
Recalling firm: LINEAGE BIOMEDICAL, INC
Quantity: 215 cartons (containing 50 pouches each)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect GTIN number on carton.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect GTIN number on carton.

Code information

Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107

Distribution pattern

US Nationwide distribution in the states of Michigan and South Carolina.