CLASS III ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report
NavaClick Syringe and Needle recalled by Lineage Biomedical
Lineage Biomedical is recalling NavaClick Syringe and Needle, distributed nationwide in the US. The recall was initiated on 12 Jul 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2535-2024
- FDA event ID
- 94963
- Recalling firm
- Lineage Biomedical, Stuart, FL
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 12 Jul 2024
- FDA classified
- 8 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 12 Jul 2024 | Recall initiated by company | |
| 8 Aug 2024 | Classified by FDA | +27 days |
| 14 Aug 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect GTIN number on carton.
Product as listed by the FDA
NavaClick Syringe and Needle, Model Number LIN02
Where it was distributed
US Nationwide distribution in the states of Michigan and South Carolina.
Questions about this recall
Is NavaClick Syringe and Needle recalled?
Yes. Lineage Biomedical recalled NavaClick Syringe and Needle on 12 Jul 2024. The recall is Class III and its status is Ongoing. Recall number Z-2535-2024.
Why was it recalled?
Incorrect GTIN number on carton.
Which lots are affected?
Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107
Where was it sold?
US Nationwide distribution in the states of Michigan and South Carolina.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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